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Based on a review of documentation and interviews, the facility failed to ensure that the hospital's x-ray equipment was maintained in safe, operating condition and in accordance with policies and acceptable standards of practice, as guidelines for the proper levels of radiation used during radiographic procedures were not followed. It was determined these deficient practices created an Immediate Jeopardy situation and placed patients at risk of potential harm, serious injury and subsequent death. These failed practices had the potential to affect all patients undergoing radiologic procedures at the facility.

A survey was conducted on 03/29/16 by a representative from the Texas Department of State Health Services Radiology Division. One "finding of fact" from this survey was, "From on or before April 25, 2013 until March 30, 2016, SCMD performed x-rays on patients using General Electric Radiographic X-ray Unit, model 225997622975, serial number 22975HL7 and General Electric Portable X-ray Unit, model number AMX4 2275938-7, serial number 984250WKl , with entrance exposure rates that exceed those allowed under 25 TAC §289.2270)." This finding lead to the initiation of an immediate jeopardy investigation at the facility on 03/30/16.

Cross refer to C0222.

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30250

Based on a review of documentation and interviews, the facility failed to have a preventive maintenance program, specific to X-ray equipment, to ensure that all all essential mechanical, electrical, and patient care equipment was maintained in safe operating condition.

Findings included:

Facility policy #2301 titled "Preventive Maintenance" states, in part:
"POLICY:
· The Radiology Director shall maintain a schedule for preventive maintenance of all equipment in the Radiology Department.
· Imaging and radiologic equipment (whether used for diagnostic or therapeutic purposes) shall be inspected, tested and maintained in accordance with manufacturer's recommendations."

Facility Critical Indicator Bank [for Quality Assurance, Performance Improvement] for Radiology lists the following critical indicator:
"CI [critical indicator] #6: Radiology equipment will be well maintained and in complete working order."

Facility Critical Indicator for Radiology lists the following:
"Critical Indicator #6: Radiology equipment will be well maintained and in complete working order.
Criteria: Staff will follow the Radiology maintenance program as outlined and ensure all appropriate equipment checks are done on a daily, weekly, monthly, bi-annual and yearly basis (i.e. PMs [preventive maintenance], calibrations, physicist checks etc.)"

The facility Radiology Quality Assurance and Preventative Maintenance binder contained no schedule for preventive maintenance for the fixed and/or portable X-ray machines, per facility based policy. In an interview on 03/31/16, staff member #2, was asked how often the [contracted preventative maintenance provider] provided preventative maintenance to the radiology machines. They replied, "I asked him how often he comes, usually yearly. He said he's not required to come yearly."

The facility was unable to locate a contract with [contracted radiology maintenance company] that addressed maintenance (preventive and/or routine) for the X-Ray equipment. In an interview on 03/31/16, staff member #3, stated, "I believe we don't have one. I could't find one." The contact provided to the surveyors dated 12/14/07 was a service contract specific to the preventive maintenance service of Computerized Tomography equipment. This contract did not address the X-ray equipment or any preventative maintenance schedule for that equipment.

GE "Proteus R/a System (32, 50, 65, 80k W) Services Manual" © 2002 provided by the facility stated in part,
"Chapter 8 PLANNED MAINTENANCE
Section 1
Preventative Maintenance Action List
The Proteus System does not require any planned maintenance to be performed for a 13 month period following installation. The following table lists the required planned maintenance activities..."

The table indicated that a visual inspection and functional checks of the machine are to be performed at a frequency of every 12 months.

GE "AMX 4+ Periodic Maintenance" manual (Direction 2173227-100, Revision 10)
Copyright 1996© by General Electric Company, found at:
stated in part,
"SECTION 2 - PM SCHEDULES
Your AMX 4+ does not require any planned maintenance to be performed for a 13 month period following installation. PM should begin in the 13th month that follows your system's installation anniversary date. Following the 13th month, PMs should be performed at the frequency indicated in Section 3 that follows ....

SECTION 3 - INSPECTION
The recommended interval between maintenance checks is 12 months. The following flowchart shows the recommended sequence for performing an annual periodic maintenance check on the AMX-4+."

Preventative Maintenance Records from [contracted maintenance provider] revealed:
· On 02/25/16 a service report indicated that preventative maintenance was performed on a GE machine model 225998 with serial number 23041HL7.
· On 12/12/13 a service report indicated that all routine and maintenance inspection was performed on a GE machine model "Prodius" rad system with serial number 23041HL7.
There were two service reports for issues with the Proteus machine (stationary machine)
· On 10/27/14 a service report for a GE Proteus serial number 22512HL8 stated there was a service request for "console will not display techniqu ".
· On 02/13/13 a service report for a "Proteus 65kw" indicated "upon power up console did not display technique, kup, MA, time".
Service reports for the portable General Electric Radiographic X-ray serial number AMX IV Plus Serial Number 984250WK1:
· On 03/02/16 calibration was performed.
· On 02/26/16 preventive maintenance and calibration was performed.

During a tour of the radiology department on 03/31/16, it was observed the stationary General Electric Radiographic X-ray unit located in the X-ray room had a model number of 2259976 and a serial number of 22975HL7. These numbers did not match the model and serial numbers indicated on the service reports above dated 02/25/16 and 12/12/13. The only item in the room matching the serial number 23041HL7 was the X-ray table.

In an interview on 03/31/16 at 11:30 AM, staff member #2 stated, "I figured out where he (representative from preventative maintenance company) got that number from, it's the x-ray table. I'm not sure if that's what he should have put, but that's what he got it from and he put on the FDA form when they replaced the call meter."

The portable General Electric Radiographic X-ray had a serial number of 984250WK1 which matched the serial number on the above service reports dated 03/02/16 and 02/26/16.

Based on the above documentation, interview, and observations, the facility failed to develop and/or maintain a schedule for preventative maintenance for the facility X-ray machines. The facility failed to ensure that preventative maintenance was performed per the manufacturer recommendations (every 12 months). According to the service records, there was no documented preventative maintenance on the stationary X-ray for 2014 and 2015. The portable X-ray machine only had service records for 2016. The service records also had model and serial numbers documented that did not match the modle and serial number for the stationary X-ray machine.

Failure to establish and monitor a preventative maintenance schedule for X-ray equipment placed patients at risk of faulty equipment being used. This facility had documented high techniques with a recommendation to address from the physicist starting on 04/25/13. These issues might have been identified and addressed earlier with routine maintenance, potentially preventing the exposure of patients to radiation rates exceeding those allowed under 25 TAC §289.2270).

The above findings were confirmed with the facility administrator on 03/31/16.

Based on a review of documentation and interviews, the facility failed to ensure the governing body was notified of and/or addressed the reports and recommendations made since 4-25-13 (regarding the standard level of radiation needed to produce a diagnostic result), by the physicist performing annual inspection of the facility's radiologic equipment. The facility also failed to have a preventive maintenance program, specific to X-ray equipment, to ensure that all all essential mechanical, electrical, and patient care equipment was maintained in safe operating condition. It was determined these deficient practices created an Immediate Jeopardy situation and placed patients at risk of potential harm, serious injury and subsequent death. These failed practices had the potential to affect all patients undergoing radiologic procedures at the facility. Cross refer to C0222, C0241, and C0283.

30250

Based on a review of documentation and interview, the facility failed to ensure that a a governing body or an individual that assumes full legal responsibility for determining, implementing, and monitoring policies governing the CAH's total operation and for ensuring that those policies are administered so as to provide quality health care in a safe environment.

Findings included:

The facility failed to follow established policies and manufacturer recommendations to ensure X-rays were provided in a safe environment.

Facility policy titled "Schleicher County Medical Center Departmental Quality Assurance Plan: Radiology" states, in part:
"Statement of Function

It is the purpose and responsibility of the Radiology Department to provide a safe environment for patients and employees during radiology exams and to perform physician requested exams for patients in a professional manner to insure patient confidence of quality care. Scope of Radiology contains:

Assurance of patient and personnel safety through ongoing evaluation in compliance with State Radiation Control regulations. (Badge reports, equipment documentation, etc.)"

Documentation from the contracted Physicist revealed:
* On 04/25/13, a cover letter from the physicist stated, "All of your units appear to be in good shape. My only recommendation is to lower the techniques for some of your exams in your rad room. They were too high."
* On 03/20/14, a cover letter from the physicist stated, "All of your units appear to be in good shape. My only recommendation is to lower the techniques for some of your exams in your rad room. They were too high."
* On 06/15/15, a cover letter from the physicist stated, "All of your units appear to be in good shape. However the exams that we looked at give too high an exposure. Please change your techniques to correct that."

A review of the facility QAPI (Quality Assurance Performance Improvement) meeting minutes held in 2013, 2014, 2015 and 2016 revealed no mention of the incorrect techniques referenced in the physicist's reports for the same years. Staff member #1 stated regarding the letters from the physicist, "This has just been coming and not getting out of the department and he hasn't reached out at all to us to say you haven't fixed this." The staff member added that regarding prior physicist inspections of the radiology department, "Here's how it went in the past with the previous predecessor. She would say, 'the physicist is coming. He's going to sign off on our stuff.' I would ask, how did it go? 'It went good, he said what he always says'." These issues were not reported to administration or any further than the Radiology department, preventing the involvement of administration to address this issue which has the potential health hazard of exposing patients to higher rates of radiation than recommended.

Facility policy #2301 titled "Preventive Maintenance" states, in part:
"POLICY:
· The Radiology Director shall maintain a schedule for preventive maintenance of all equipment in the Radiology Department.
· Imaging and radiologic equipment (whether used for diagnostic or therapeutic purposes) shall be inspected, tested and maintained in accordance with manufacturer's recommendations."

Facility Critical Indicator Bank [for Quality Assurance, Performance Improvement] for Radiology lists the following critical indicator:
"CI [critical indicator] #6: Radiology equipment will be well maintained and in complete working order."

Facility Critical Indicator for Radiology lists the following:
"Critical Indicator #6: Radiology equipment will be well maintained and in complete working order.
Criteria: Staff will follow the Radiology maintenance program as outlined and ensure all appropriate equipment checks are done on a daily, weekly, monthly, bi-annual and yearly basis (i.e. PMs [preventive maintenance], calibrations, physicist checks etc.)"

The facility Radiology Quality Assurance and Preventative Maintenance binder contained no schedule for preventive maintenance for the fixed and/or portable X-ray machines, per facility based policy. In an interview on 03/31/16, staff member #2, was asked how often the [contracted preventative maintenance provider] provided preventative maintenance to the radiology machines. They replied, "I asked him how often he comes, usually yearly. He said he's not required to come yearly."

The facility was unable to locate a contract with [contracted radiology maintenance company] that addressed maintenance (preventive and/or routine) for the X-Ray equipment. In an interview on 03/31/16, staff member #3, stated, "I believe we don't have one. I couldn't find one." The contact provided to the surveyors dated 12/14/07 was a service contract specific to the preventive maintenance service of Computerized Tomography equipment. This contract did not address the X-ray equipment or any preventative maintenance schedule for that equipment.

GE "Proteus R/a System (32, 50, 65, 80k W) Services Manual" © 2002 provided by the facility stated in part,
"Chapter 8 PLANNED MAINTENANCE
Section 1
Preventative Maintenance Action List
The Proteus System does not require any planned maintenance to be performed for a 13 month period following installation. The following table lists the required planned maintenance activities..."

The table indicated that a visual inspection and functional checks of the machine are to be performed at a frequency of every (12 months).

GE "AMX 4+ Periodic Maintenance" manual (Direction 2173227-100, Revision 10)
Copyright 1996© by General Electric Company, found at:
stated in part,
"SECTION 2 - PM SCHEDULES
Your AMX 4+ does not require any planned maintenance to be performed for a 13 month period following installation. PM should begin in the 13th month that follows your system's installation anniversary date. Following the 13th month, PMs should be performed at the frequency indicated in Section 3 that follows ....

SECTION 3 - INSPECTION
The recommended interval between maintenance checks is 12 months. The following flowchart shows the recommended sequence for performing an annual periodic maintenance check on the AMX-4+."

Preventative Maintenance Records from [contracted maintenance provider] revealed:
· On 02/25/16 a service report indicated that preventative maintenance was performed on a GE machine model 225998 with serial number 23041HL7.
· On 12/12/13 a service report indicated that all routine and maintenance inspection was performed on a GE machine model "Prodius" rad system with serial number 23041HL7.
There were two service reports for issues with the Proteus machine (stationary machine)
· On 10/27/14 a service report for a GE Proteus serial number 22512HL8 stated there was a service request for "console will not display techniqu ".
· On 02/13/13 a service report for a "Proteus 65kw" indicated "upon power up console did not display technique, kup, MA, time".
Service reports for the portable General Electric Radiographic X-ray serial number AMX IV Plus Serial Number 984250WK1:
· On 03/02/16 calibration was performed.
· On 02/26/16 preventive maintenance and calibration was performed.

During a tour of the radiology department on 03/31/16, it was observed the stationary General Electric Radiographic X-ray unit located in the X-ray room had a model number of 2259976 and a serial number of 22975HL7. These numbers did not match the model and serial numbers indicated on the service reports above dated 02/25/16 and 12/12/13. The only item in the room matching the serial number 23041HL7 was X-ray table.

In an interview on 03/31/16 at 11:30 AM, staff member #2 stated, "I figured out where he (representative from preventative maintenance company) got that number from, it's the x-ray table. I'm not sure if that's what he should have put, but that's what he got it from and he put on the FDA form when they replaced the call meter."

The portable General Electric Radiographic X-ray had a serial number of 984250WK1 which matched the serial number on the above service reports dated 03/02/16 and 02/26/16.

The facility failed to ensure that revelant information regarding radiology equipment and the need for the techniques to be adjusted was reported to the administrator or the quality improvement committee. This facility had documented high techniques with a recommendation to address from the physicist starting on 04/25/13. Reporting the high techniques and recommendations to the administrator and the Quality Improvement committee could have potentially prevented the exposure of patients radiation rates exceeding those allowed under 25 TAC §289.2270).

The facility also failed to develop and/or maintain a schedule for preventative maintenance for the facility X-ray machines, per policy. The facility failed to ensure that preventative maintenance was performed per manufacturer's recommendations (every 12 months). According to the service records, there was no documented preventative maintenance on the stationary X-ray for 2014 and 2015. The portable X-ray machine only had service records for 2016. The service records also had serial numbers documented that did not match the serial number for the stationary X-ray machine. Failure to establish and monitor a preventative maintenance schedule for X-ray equipment, placed patients at risk of faulty equipment being used. This facility had documented high techniques with a recommendation to address from the physicist starting on 04/25/13. These issues might have been identified and addressed earlier with routine preventative maintenance.

The above findings were confirmed with the facility administrator on 03/31/16.

30250

Based on a review of documentation and interviews, the facility failed to follow recommendations made since 4-25-13 (regarding the standard level of radiation needed to produce a diagnostic result), by the physicist performing annual inspection of the facility's radiologic equipment. .It was determined these deficient practices created an Immediate Jeopardy situation and placed patients at risk of potential harm, serious injury and subsequent death. These failed practices had the potential to affect all patients undergoing radiologic procedures at the facility. Cross refer to C0283.

30250

Based on review of documentation and interview, the facility failed to ensure that radiology do not expose patients or personnel to radiation hazards.

Findings included:

During the immediate jeopardy investigation from 03/30/16 through 03/31/16 the following findings were made:

Facility policy #2003 titled "Patient Safety" stated, in part:

"POLICY:
Patient safety shall be at all times our highest priority. No action shall be undertaken which would knowingly be harmful to the patient."

Facility policy #2110 titled "Recommended Operating Procedures For Medical X-Rays" states, in part:
"POLICY:
...
No person shall operate or permit the operation of x-ray equipment unless the equipment and installation meet the applicable requirements of the State of Texas Radiation Control Regulations.
The operator MUST be aware of and implement all applicable requirements of the State of Texas Radiation Control Regulations.
...
Any apparent malfunction of the x-ray apparatus shall be reported to the person responsible for radiation safety."

In an interview on 03/30/16 at 2:25 PM, staff member #1 was asked if the facility was aware that their x-ray equipment was faulty and emitting increased radiation levels. Staff member #1 replied, "Yes. We get the physicist report, that's gone to my radiology director, it (physicist report) said the same thing it's always said, it said our techniques were high. This past times he was here it was too high. The technique was too high which is the exposure." In regards to facility actions after the reports of high exposure, staff member #1 stated, " What she (radiology director) did is she lowered the deal. We got word from the radiologist that the diagnostics were too low, they weren't able to read the x-rays. She had to raise it to get a diagnostic level. She was under the impression if the report from the physicist is good that we're okay."

Reports from the Physicist revealed:
* On 04/25/13, a cover letter from the physicist stated, "All of your units appear to be in good shape. My only recommendation is to lower the techniques for some of your exams in your rad room. They were too high."
* On 03/20/14, a cover letter from the physicist stated, "All of your units appear to be in good shape. My only recommendation is to lower the techniques for some of your exams in your rad room. They were too high."
* On 06/15/15, a cover letter from the physicist stated, "All of your units appear to be in good shape. However the exams that we looked at give too high an exposure. Please change your techniques to correct that."

When the physicist letter from 2014 was reviewed by staff member #1, they stated, "That's pretty definitive it was too high." Staff member #1 stated regarding the letters from the physicist, "This has just been coming and not getting out of the department and he hasn't reached out at all to us to say you haven't fixed this." The staff member added that regarding prior physicist inspections of the radiology department, "Here's how it went in the past with the previous predecessor. She would say, 'the physicist is coming. He's going to sign off on our stuff.' I would ask, how did it go? 'It went good, he said what he always says'."

A signed letter from staff member #2 to the X-Ray Inspector with the Texas Department of State Health Services dated 03/29/16 stated, "I was made aware on June 15, 2015 by our Physicist, [name], that the techniques used were too high and needed to be lowered. Upon lowering the techniques, it was found to produce underpenetrated, non-diagnostic images."

In an interview with staff member # 2, on 03/30/16 at 3:00 PM, they were asked when they were first made aware of physicist letters with recommendations as the Radiology Director. She replied, "June of 2015". The staff member verified they responded to the recommendation in this letter by lowering the technique. After lowering the machine technique, "The radiologist noted them as undiagnostic, there was not enough penetration." The technique was subsequently raised again by this employee.

Staff member # 2 was asked if they notified the physicist of these changes to the technique "No I wasn't aware of, I didn't know when he noted that in his cover letter, that it was our exposure failing the EPE (equipment performance evaluation). I took it as a recommendation. I know when I was tech before that [previous radiology director] mention that before and we were unable to lower our technique. I didn't know it was us failing the EPE and needing a 30 day response. Since he noted it in cover letter and didn't say anything about, I thought it was more of a recommendation."

Staff member #2 was asked if they notified anyone, including the administrator about the adjustments to the technique. "I think we let [administrator] know what physicist noted and that he's noted that before in previous years. As far as saying we were unable to fix it, that I'm not sure if he was told or not." The facility did not address the high exposure, beyond the one time adjustment of the technique, until the survey by the Radiology department of the Texas Department of State Health.
* While on site for the immediate jeopardy complaint (03/30/16 through 03/31/16) the health facility compliance surveyors were provided documentation stating that the facility contacted the contracted physicist and preventative maintenance company on 03/30/16 to address the issues with the stationary and portable X-ray machines.
* It was also observed that on 03/31/16, at 4:00 PM that a sign stating " Do Not Use Unit Further Notice " had been place on both the machines. It was confirmed that no patients had not received X-rays on 03/30/16 or 03/31/16 due to the Emergency Order from the Texas Department of State Health Services. Staff member #1 verbally confirmed the facility would not be using the X-ray equipment (fixed or portable) until the issues identified in the Emergency Order were corrected.

The population of patients receiving X-rays on the GE stationary X-ray machine at the facility from 04/25/13 through 03/30/16 was 1,160. The population of patients receiving X-rays on the GE stationary X-ray machine at the facility from 06/15/15 through 03/30/16 was 835.

According to the physicists reports, the technique levels had been high with a recommendation to make adjustments since 04/25/13. This issue was not addressed, per interview with the Radiology Director, until June 2015. The facility's failure to address the high exposures (noted in the the physicist reports to the facility) in a timely manner, placed patients at risk of harm due to radiation exposure rates exceeding those allowed under 25 TAC §289.2270. At the time of this survey on 03/30/16 and 03/31/16, the X-ray machines had not been tested, calibrated, or adjusted to address this health risk for patients, however, the facility had stopped using the machines.

The facility also failed to follow their own policies and manufacturer recommendations regarding the maintenance of their radiology equipment. See C0222.


The above findings were confirmed in an interview with the facility administrator on 03/31/16.