The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

MARGARET R PARDEE MEMORIAL HOSPITAL 800 N JUSTICE ST HENDERSONVILLE, NC 28791 May 3, 2017
VIOLATION: GOVERNING BODY Tag No: A0043
Based on hospital policies and procedures review, medical record reviews, and staff interviews, the hospital's Governing Body failed to provide oversight of the hospital's Radiology Department to ensure systematic assessments of patients' potential allergies to contrast media were assessed by staff before administering contrast media to patients. The cumulative effect of these systemic problems resulted in the hospital's inability to ensure patients remained safe from potential harm when administered contrast media.

Findings included:

The hospital's radiology department leadership failed to demonstrate an organized radiology service to meet the needs of patients by failing to ensure patient safety during Computed Tomography (CT) scanning by failing to have assessment of patients' potential allergies to contrast media assessed by staff before administering the contrast media to patients presenting to the hospital's radiology department.

~Cross refer to 482.26 Radiologic Services Condition: Tag 0528.
VIOLATION: CONTENT OF RECORD - INFORMED CONSENT Tag No: A0466
Based on hospital policies and procedures review, medical record reviews and staff interviews, the hospital's radiologic staff failed to ensure that contrast media consents were completed prior to patients receiving IV (intravenous) contrast media in 7 of 10 sampled patients receiving contrast media (Patients #5, #4, #6, #8, #10, #1, and #2).

Findings included:

Review on 05/02/2017 of the hospital's policy and procedure "Intravenous Contrast Media Injection by the Technologist" (Last Revision: 07/03/2015), revealed "Procedure: Contrast-enhances procedures performed in the Radiology Department fall under the supervision of the Radiologist. All Technologists are given permission to inject intravenous contrast media providing that the following guidelines are in use: 5. An informed consent is obtained with patient's history of allergies and medications documented and signed. 11. Every patient that receives iodinated contrast must read and sign the attached consent form. The technologist will ensure that this form is completed prior to all contrast injections. All sections must be completed and reviewed with the patient."

1. Closed medical record review on 05/02/2017 for patient #5 revealed the patient presented to the hospital's outpatient Radiology Department on 03/17/2017 for a radiologic service procedure of "CT (computed tomography) scan of Chest with IV (intravenous) Contrast." Documentation of the hospital's form "Authorization/Consent for Injection of Contrast Media" for the patient's 03/17/2017 procedure consent revealed the staff failed to complete the question "Past injection of contrast media" Yes__ No___". No documentation was found to determine if the patient ever received a past injection of contrast media. The documentation review also revealed that no patient time of consent was found on the consent form.

Interview on 05/03/2017 at 1051 with the hospital's Director of Imaging Services revealed the staff should complete the patient's consent form completely. The interview confirmed the medical record finding.

2. Closed medical record review on 05/02/2017 for patient #4 revealed the patient presented to the hospital's outpatient Radiology Department on 12/21/2016 for a radiologic service procedure of "CT (computed tomography) scan of Abdomen/Pelvis with IV (intravenous) Contrast." Documentation of the hospital's form "Authorization/Consent for Injection of Contrast Media" for the patient's 12/21/2016 procedure consent revealed the staff failed to complete the question "Past injection of contrast media" Yes__ No___". No documentation was found to determine if the patient ever received a past injection of contrast media.

Interview on 05/03/2017 at 1051 with the hospital's Director of Imaging Services revealed the staff should complete the patient's consent form completely. The interview confirmed the medical record finding.

3. Closed medical record review on 05/02/2017 for patient #6 revealed the patient presented to the hospital's outpatient Radiology Department on 03/17/2017 for a radiologic service procedure of "CT (computed tomography) scan of Abdomen/Pelvis with IV (intravenous) Contrast." Documentation of the hospital's form "Authorization/Consent for Injection of Contrast Media" for the patient's 03/17/2017 procedure consent revealed that the staff failed to obtain the patient's date and time for consenting to IV contrast media.

Interview on 05/03/2017 at 1051 with the hospital's Director of Imaging Services revealed the staff should complete the patient's consent form completely. The interview confirmed the medical record finding.

4. Closed medical record review on 05/02/2017 for patient #8 revealed the patient presented to the hospital's outpatient Radiology Department on 04/29/2017 for a radiologic service procedure of "CT (computed tomography) scan of Abdomen/Pelvis with IV (intravenous) Contrast." Documentation of the hospital's form "Authorization/Consent for Injection of Contrast Media" for the patient's 04/29/2017 procedure consent revealed that the staff failed to obtain the patient's time for consenting to IV contrast media.

Interview on 05/03/2017 at 1051 with the hospital's Director of Imaging Services revealed the staff should complete the patient's consent form completely. The interview confirmed the medical record finding.

5. Closed medical record review on 05/02/2017 for patient #10 revealed the patient presented to the hospital's outpatient Radiology Department on 04/30/2017 for a radiologic service procedure of "CT (computed tomography) scan of Abdomen/Pelvis with IV (intravenous) Contrast." Documentation of the hospital's form "Authorization/Consent for Injection of Contrast Media" for the patient's 04/30/2017 procedure consent revealed that the staff failed to obtain the patient's time for consenting to IV contrast media.

Interview on 05/03/2017 at 1051 with the hospital's Director of Imaging Services revealed the staff should complete the patient's consent form completely. The interview confirmed the medical record finding.

6. Closed medical record review on 05/02/2017 for patient #1 revealed the patient presented to the hospital's outpatient Radiology Department on 06/16/2016 for a radiologic service procedure of "CT (computed tomography) scan of Abdomen/Pelvis with IV (intravenous) Contrast." Documentation of the hospital's form "Authorization/Consent for Injection of Contrast Media" for the patient's 06/16/2016 procedure consent revealed the staff failed to complete the question "Past injection of contrast media" Yes__ No___". No documentation was found to determine if the patient ever received a past injection of contrast media. The documentation review also revealed that no patient time of consent was found on the consent form.

Interview on 05/03/2017 at 1051 with the hospital's Director of Imaging Services revealed the staff should complete the patient's consent form completely. The interview confirmed the medical record finding.

7. Closed medical record review on 05/02/2017 for patient #2 revealed the patient presented to the hospital's outpatient Radiology Department on 07/01/2016 for a radiologic service procedure of "CT (computed tomography) scan of Abdomen/Pelvis with IV (intravenous) Contrast." Documentation of the hospital's form "Authorization/Consent for Injection of Contrast Media" for the patient's 07/01/2016 procedure consent revealed that the staff failed to obtain the patient's date and time for consenting to IV contrast media.

Interview on 05/03/2017 at 1051 with the hospital's Director of Imaging Services revealed the staff should complete the patient's consent form completely. The interview confirmed the medical record finding.
VIOLATION: RADIOLOGIC SERVICES Tag No: A0528
Based on hospital policies and procedures review, medical record reviews, and staff interviews, the hospital's radiology department leadership failed to demonstrate an organized radiology service to meet the needs of the patients and ensure patient health and safety. The cumulative effect of these systemic problems resulted in the hospital's inability to ensure that patients remained safe from potential harm when administered contrast agents resulting in an identification of Immediate Jeopardy.

Findings included:

A) The hospital's radiologic services failed to implement policies and procedures to provide safety for patients receiving contrast media prior to diagnostic radiologic procedures and by failing to obtain a patient's history of medications and allergies for contrast media in 1 of 1 sampled patients (Patient #3) with a known allergy, who received IV (Intravenous) Contrast then developing an anaphylactic reaction; and in 10 of 10 sampled patients receiving radiologic procedures with administration of contrast media (Patient's #3, #1, #2, #4, #5, #6, #7, #8, #9, #10).

~ Cross refer to 482.26 (b) Radiology Services Standard Tag 0535

B) The hospital's radiologic staff failed to ensure that contrast media consents were completed prior to patients receiving IV (intravenous) contrast media in 7 of 10 sampled patients receiving contrast media (Patients #5, #4, #6, #8, #10, #1, and #2).

~ Cross refer to 482.24 (c)(4)(v) Medical Records Services Standard Tag 0466
VIOLATION: SAFETY POLICY AND PROCEDURES Tag No: A0535
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on hospital policies and procedures review, medical record reviews, and staff interviews, the hospital's radiologic services failed to implement policies and procedures to provide safety for patients receiving contrast media prior to diagnostic radiologic procedures and by failing to obtain a patient's history of medications and allergies for contrast media in 1 of 1 sampled patients (Patient #3) with a known allergy, who received IV (Intravenous) Contrast then developing an anaphylactic reaction; and in 10 of 10 sampled patients (Patient's #3, #1, #2, #4, #5, #6, #7, #8, #9, #10) receiving radiologic procedures with administration of contrast media.

Findings included:

Review on 05/02/2017 of the hospital's policy and procedure, "Intravenous Contrast Media Injection by the Technologist" (Last Revision: 07/03/2015), revealed "Procedure: Contrast-enhances procedures performed in the Radiology Department fall under the supervision of the Radiologist. All Technologists are given permission to inject intravenous contrast media providing that the following guidelines are in use: 5. An informed consent is obtained with patient's history of allergies and medications documented and signed. 11. Every patient that receives iodinated contrast must read and sign the attached consent form. The technologist will ensure that this form is completed prior to all contrast injections. Al sections must be completed and reviewed with the patient."

1. Closed medical record review on 05/02/2017 for patient #3 revealed the [AGE] year old patient presented to the hospital's outpatient Radiology Department on 07/01/2016 for a radiologic service procedure of "CT (computed tomography) scan of Abdomen, Pelvis and Chest with oral and IV (intravenous) Contrast." Review of the patient's record revealed the hospital's Radiology Department received a faxed order dated 06/23/2016 at 1047 from the patient's oncology physician for the ordered CT procedure. Review of the faxed order revealed documentation as "Allergies; Ingredient Codeine Iodine". The review revealed the faxed order was produced with the patient's medical record during record review on 05/02/2017. The review of the medical record revealed documentation on the form "Authorization/Consent for Injection of Contrast Media" dated for 07/01/2016 by CT Technologist #2. No documentation was found on the form for assessment of any patient allergies. The documentation revealed that the patient signed the consent form on 07/01/2016 at 0935. On 07/01/2016 at 1051, documentation by CT Technologist #1 revealed that the patient was administered "80 ml (milliliters) Opti Ray 320 (Contrast media) IV with oral hydration." No documentation was found in the medical record that the patient's allergies were reviewed for "Iodine" by the CT Technologist or the supervising Radiologist before administration of the contrast media on 07/01/2016 at 1051.

Further medical record review by the hospital's Emergency Department Physician #1 on 07/01/2016 at 1043 (total of 8 minutes before IV contrast administration) revealed that the patient was receiving outpatient CT and after receiving contrast injection, immediately complained of throat tightening while waiting for Benadryl. The documentation from the physician revealed that he responded to code blue on CT scan table for the patient who was pulseless, apneic and in PEA (Pulseless Electrical Activity) as initial rhythm. The patient was administered epinephrine and atropine (Medications used in Code Blue) and the patient was intubated by the anesthesiologist (unidentified) and placed on mechanical intubation before admission to the hospital's ICU (Intensive Care Unit). Documentation by Radiologist #1 on 07/01/2016 at 1152 revealed "Addendum: Patient had severe allergic reaction immediately post infection of the IV contrast. CPR (Cardiopulmonary resuscitation) was initiated and the patient was intubated. Patient was then transported to the emergency room ."

Interview on 05/02/2017 at 1534 with CT Technician #3 revealed that on a Thursday (Unknown Date and time) that she remembered patient #3 calling the Radiology Department to inform her that she was allergic to "Shellfish" and wanted to make sure it was alright to receive contrast. The interview revealed that the CT Technician told the patient that allergy to shellfish was not a concern but that she would check with the Radiologist just to be sure. The interview revealed that she placed the patient on hold (telephone) and asked Radiologist (unidentified) if the patient's shellfish allergy was ok to receive contrast. The technician stated that she told the patient it was not a concern. The interview also revealed that the technician did not document anywhere in the patient's medical record the conversation and only left a note on the computer screen for the staff to see the following day for the patient's procedure. The technician also reported that there was not anywhere on the hospital's consent forms to document patient allergies and that she would list allergies if it was up to her.

Interview on 05/03/2017 at 0904 with CT Technician #1 revealed that she was working on 07/01/2016 when patient #3 came in for her CT. The interview also revealed that she verified the physician order before the patient's procedure (unidentified time) and say that she had iodine allergy. The interview revealed that she did not make Radiologist aware because iodine allergy was the same as shellfish allergy according to the scientific studies and that the staff was not supposed to even ask Radiologists before administering contrast if it was shellfish. The interview also revealed that she does not ask what allergies patients have and only asks what is on the contrast consents. The interview also revealed that the technician administered the IV contrast to patient #3 on 07/01/2016 before the patient's anaphylactic reaction.

Interview on 05/03/2017 at 0924 with CT Technician #2 revealed that she obtained the informed consent from patient #3 before the patient's administration of IV contrast on 07/01/2016. The interview revealed that she did not ask the patient about allergies before obtaining the patient's consent. The interview did reveal that the patient told her that she had an allergy to shellfish, but that she did not document the allergy as the hospital forms have no place to ask for or document allergies. The interview also revealed that the Radiologist was not told about the allergy by her as the Radiologist tell us that iodine contrast used in the contrast media is different than in shellfish.

Interview on 05/03/2017 at 1030 with the hospital's Risk Manager, Quality and Accreditation revealed that she became aware of patient #3's event after the patient's husband complained to the hospital's administration. The interview revealed the husband was concerned that the patient's allergies was not taken seriously and his wife's care was like playing "Russian roulette." The interview also revealed the patient's care was reviewed and it was found that the hospital's protocol was followed. The interview did reveal concerns were found in lack of documentation for the patient's allergies. The interview also revealed that no action has been taken prior to 05/02/2017 reference allergies not being obtained by the Radiology Department staff for outpatient procedures requiring contrast media. The interview revealed no QAPI (Quality Assessment Performance Improvement) had been completed reference the the radiology staff not obtaining allergies to medications and foods before receiving contrast media. The interview revealed that the Radiologist supervising patient #3's care on 07/01/2016 was not available for interview during the investigation.

Interview on 05/03/2017 at 1051 with the hospital's Director of Imaging Services revealed that she reviewed the care of patient #3 on 07/01/2016 and did have concerns with the lack of documentation for patient allergies to contrast media. The interview revealed that there was been discussion ongoing with the hospital's Radiologists but that there was no documentation in the quarterly meetings for Radiology Services to validate the discussions.

2. Closed medical record review on 05/02/2017 for patient #1 revealed the patient presented to the hospital's outpatient Radiology Department on 06/16/2016 for a radiologic service procedure of "CT (computed tomography) scan of Abdomen/Pelvis with IV (intravenous) Contrast." Documentation in the patient's medical record for 06/16/2016 revealed there was no documentation found for assessment of any patient allergies.

Interview on 05/03/2017 at 1051 with the hospital's Director of Imaging Services revealed there was no documentation for patient #1 having any allergies to medications and/or food by the staff in Radiology before the administration of contrast media.

3. Closed medical record review on 05/02/2017 for patient #2 revealed the patient presented to the hospital's outpatient Radiology Department on 07/01/2016 for a radiologic service procedure of "CT (computed tomography) scan of Abdomen/Pelvis with IV (intravenous) Contrast." Documentation in the patient's medical record for 07/01/2016 revealed there was no documentation found for assessment of any patient allergies.

Interview on 05/03/2017 at 1051 with the hospital's Director of Imaging Services revealed there was no documentation for patient #2 having any allergies to medications and/or food by the staff in Radiology before the administration of contrast media.

4. Closed medical record review on 05/02/2017 for patient #4 revealed the patient presented to the hospital's outpatient Radiology Department on 12/21/2016 for a radiologic service procedure of "CT (computed tomography) scan of Abdomen/Pelvis with IV (intravenous) Contrast." Documentation in the patient's medical record for 12/21/2016 revealed there was no documentation found for assessment of any patient allergies.

Interview on 05/03/2017 at 1051 with the hospital's Director of Imaging Services revealed there was no documentation for patient #4 having any allergies to medications and/or food by the staff in Radiology before the administration of contrast media.

5. Closed medical record review on 05/02/2017 for patient #5 revealed the patient presented to the hospital's outpatient Radiology Department on 03/17/2017 for a radiologic service procedure of "CT (computed tomography) scan of Chest with IV (intravenous) Contrast." Documentation in the patient's medical record for 03/17/2017 revealed there was no documentation found for assessment of any patient allergies.

Interview on 05/03/2017 at 1051 with the hospital's Director of Imaging Services revealed there was no documentation for patient #5 having any allergies to medications and/or food by the staff in Radiology before the administration of contrast media.

6. Closed medical record review on 05/02/2017 for patient #6 revealed the patient presented to the hospital's outpatient Radiology Department on 03/17/2017 for a radiologic service procedure of "CT (computed tomography) scan of Abdomen/Pelvis with IV (intravenous) Contrast." Documentation in the patient's medical record for 03/17/2017 revealed there was no documentation found for assessment of any patient allergies.

Interview on 05/03/2017 at 1051 with the hospital's Director of Imaging Services revealed there was no documentation for patient #6 having any allergies to medications and/or food by the staff in Radiology before the administration of contrast media.

7. Closed medical record review on 05/02/2017 for patient #7 revealed the patient presented to the hospital's outpatient Radiology Department on 09/05/2016 for a radiologic service procedure of "CT (computed tomography) scan of Abdomen/Pelvis with IV (intravenous) Contrast." Documentation in the patient's medical record for 09/05/2016 revealed there was no documentation found for assessment of any patient allergies.

Interview on 05/03/2017 at 1051 with the hospital's Director of Imaging Services revealed there was no documentation for patient #7 having any allergies to medications and/or food by the staff in Radiology before the administration of contrast media.

8. Closed medical record review on 05/02/2017 for patient #8 revealed the patient presented to the hospital's outpatient Radiology Department on 04/29/2017 for a radiologic service procedure of "CT (computed tomography) scan of Abdomen/Pelvis with IV (intravenous) Contrast." Documentation in the patient's medical record for 04/29/2017 revealed there was no documentation found for assessment of any patient allergies.

Interview on 05/03/2017 at 1051 with the hospital's Director of Imaging Services revealed there was no documentation for patient #8 having any allergies to medications and/or food by the staff in Radiology before the administration of contrast media.

9. Closed medical record review on 05/02/2017 for patient #9 revealed the patient presented to the hospital's outpatient Radiology Department on 04/28/2017 for a radiologic service procedure of "CT (computed tomography) scan of Chest with IV (intravenous) Contrast." Documentation in the patient's medical record for 04/28/2017 revealed there was no documentation found for assessment of any patient allergies.

Interview on 05/03/2017 at 1051 with the hospital's Director of Imaging Services revealed there was no documentation for patient #9 having any allergies to medications and/or food by the staff in Radiology before the administration of contrast media.

10. Closed medical record review on 05/02/2017 for patient #10 revealed the patient presented to the hospital's outpatient Radiology Department on 04/30/2017 for a radiologic service procedure of "CT (computed tomography) scan of Abdomen/Pelvis with IV (intravenous) Contrast." Documentation in the patient's medical record for 04/30/2017 revealed there was no documentation found for assessment of any patient allergies.

Interview on 05/03/2017 at 1051 with the hospital's Director of Imaging Services revealed there was no documentation for patient #10 having any allergies to medications and/or food by the staff in Radiology before the administration of contrast media.

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