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.

CHRISTUS ST PATRICK HOSPITAL 524 DR MICHAEL DEBAKEY STREET LAKE CHARLES, LA 70601 March 9, 2012
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on observation, record review, and interview the hospital failed to meet the Condition of Participation for Patient Rights as evidenced by:

1) failing to ensure the hospital had an effective policy to investigate allegations of abuse, had an abuse prohibition policy that covered staff on patient abuse, or conducted abuse prohibition training during orientation and reported allegations of abuse to Department of Health Hospitals in accordance with the 24 hour reporting time frame (Louisiana Revised Statutes Title 40. Public Health and Safety Chapter 11. State Department of Health and Hospitals ?2009.2.), as evidenced by S32 entering the room of patient #20 in retaliation to a complaint filed with S8RN, Director Med/Surg, and verbally abusing her causing patient #20 to feel threatened, fear retaliation, and experience mental anguish. (#20) (see findings at A0145)

2) failing to ensure that the patient had the right to make Informed decisions regarding Blood/Blood product transfusions as evidenced by failing to ensure there was documented evidence of an Informed Consent for Blood/Blood Product transfusion on the medical record for blood administration in accordance with the hospital's policy and procedure for 1 of 31 sampled patients ( #11) and 4 of 5 focused sampled patients for Blood/Blood product administration. (#9, #R1, #R2, #R7) (see findings at A0131)

3) failing to follow their policy of investigating complaints at the lowest organizational level for 1 of 31 sampled patients and 0 of 7 random patients as evidenced by the Service Guarantee Coordinator failing to identify the incident of the painful initiation of the IV by a nonhospital employee took place in the ED, failing to document the incident on a " Problem Resolution Form " , and failing to forward the form to S11 RN Director of ED/ATC, which resulted in the incident not being investigated (#8) (See findings at A0122).

4) failing to ensure patients were being informed of their admission status as evidenced by failing to follow the Admission Criteria policy for 1 of 31 patients (#4). (See Findings at A0133).
VIOLATION: PATIENT RIGHTS: GRIEVANCE REVIEW TIME FRAMES Tag No: A0122
Based on interview and policy review, the hospital failed to follow their policy of investigating complaints at the lowest organizational level for 1 of 31 sampled patients and 0 of 7 random patients as evidenced by the Service Guarantee Coordinator failing to identify the incident of the painful initiation of the IV by a nonhospital employee took place in the ED, failing to document the incident on a " Problem Resolution Form " , and failing to forward the form to S11 RN Director of ED/ATC, which resulted in the incident not being investigated (#8).
Findings:

Record review of the Complete ED Record dated 2/7/12 at 1210 (12:10 p.m.)(pg 5 of 7) revealed documentation by S21 ED RN that S3 Service Guarantee Coordinator was in the ED talking to patient #8 about complaints of being hurt during an intravenous (IV) insertion. S21 documented S20 Paramedic student had started the IV and it was very painful.

On 3/7/12 at 3:45 p.m. in a face-to-face interview with S11 Director of ED/Ambulatory Treatment Center (ATC), she stated the paramedic students are assigned a nurse preceptor. She added the nurse preceptor supervises any clinical skills a paramedic student performs.

On 3/8/12 at 10:30 a.m. in a face-to-face interview with S3 Service Guarantee Coordinator, she stated she was called down to the ED when patient #8 was brought into the ED on 2/7/12. S3 stated patient #8 was upset because one of the paramedics who arrived at the site where patient #8 had fallen attempted to start an IV, which resulted in hurting patient #8. S3 stated as she was talking with the ED nurses at the nurses' station, a paramedic student came up to her and told her that patient #8 was upset with him (S20) because he tried to start an IV several times. S20 stated patient #8 was "flailing around" making it difficult to start an IV. S3 stated the incident of the painful IV was outside of the hospital, so she did not make an incident and/or grievance report. S3 stated since the incident occurred off the hospital grounds, she did not feel she needed to investigate the problem.

Record review of the Ambulance Service's Medical Record revealed no IV was initiated as an intervention on patient #8 on 2/7/12 when she fell at a bank and was transported to the ED.

On 3/9/12 at 9:05 a.m. in a telephone interview with S24 Risk Manager for the Ambulance Service, he stated S20 Paramedic student was evaluated by a preceptor, S25 RN ED and he had good IV skills.

On 3/9/12 at 9:15 a.m. in a telephone interview with S25 RN ED, she confirmed she was S20 Paramedic Student's preceptor on 2/7/12 and 2/8/12. S25 stated as a preceptor, her responsibility was to help him with medication administration, airway management, and IV administration. S25 added she did not see S20 attempt to initiate an IV on patient #8 because patient #8 was not her assigned patient. S25 did observe S20 initiate an IV on her patients; yet, he was unsuccessful with one patient who was a dialysis patient. S25 RN stated the paramedic student attempted the initiation of the intravenous site only once.

On 3/9/12 at 10:30 a.m. in a face-to-face interview with S28 RN ED, she confirmed she was the charge nurse on 2/7/12 in the ED. She remembers S20 Paramedic student. When asked if she supervised S20 when he attempted to initiate an IV on patient #8, S28 stated S20 had good IV skills, so no one had supervised him when he attempted to initiate the IV on patient #8. To her knowledge, S20 did not attempt more than once to start the IV on patient #8. She added no one had reported to her as the charge nurse that S20 had hurt patient #8 when he attempted to start the IV; nor had patient #8 reported to S28 that she had told S20 to stop because the IV was painful.

Record review of Policy Number RI-A-180, " Patient Rights and Organizational Ethics Policy " revised dated 11/11, (pg 1 of 5) under General Statement reveals the hospital "will establish a process to assure timely response to concerns and complaints regarding care and service." Under Section I. Policy, "Complaints are investigated at the lowest organizational level possible. The Service Guarantee Coordinator provides a central communication channel through which patient/others may express areas of concern or dissatisfaction with the services without fear of compromising present or future care. " Under Section II. Customer Concerns or Complaints, Definition of Complaint/Concern is defined as "An expression of dissatisfaction with some aspect of care and/or service. Complaints will have simple and obvious causes that can be addressed promptly, by hospital staff, to the patient's satisfaction. In this same section under Patient/Family/Compliant/Concern Process, #3 reads " A problem resolution form is completed for documentation purposes, but is considered resolved if handled at the point of service to the patient ' s satisfaction " (pg 1 of 5). Under Section III. Grievances: the Definition of Grievances is "A written or verbal complaint that has not been resolved prior to discharge by a patient, or the patient's representative, regarding the patient's care, abuse, or neglect, or the hospital's compliance with the Center for Medicare and Medicaid Services Hospital Conditions of Participation (COP). Examples of a grievance may include: Violations of rights of a patient or their representative; Employee misconduct or unprofessional conduct towards a patient, guest, or representative; Quality of Care; Premature Discharge; and Abuse or neglect."

Under Section III. Grievance Process, the steps to resolving a grievance were outlined but were not followed by the Service Guarantee Coordinator included: " 4. The recovery process will include, but not limited to the following process: The " Problem Resolution Form " is initiated by the Service Guarantee Coordinator and forwarded to the Director/Manager of the respective department. The Director/Manager will complete the " Patient Complaint Investigation Form " and return to Service Guarantee Coordinator within 7 business days. An initial letter will be sent to the patient and/or representative acknowledging receipt of the grievance by the Service Guarantee Coordinator. Every effort will be made to review the grievance within 7 days and a return call will be placed by the Service Guarantee Coordinator. The Complainant will receive a written notice of the committee ' s review. Every effort will be made for review and respond within 30 days (pg 2 of 5). " The written response will include the name of the contact person, steps taken to investigate the grievance, the result of the grievance process, and the date of completion " (pg 3 of 5).


The hospital failed to follow the Patient Rights and Organizational Ethics Policy as evidenced by the Service Guarantee Coordinator failing to identify the incident of the painful initiation of the IV by a nonhospital employee took place in the ED, failing to document the incident on a " Problem Resolution Form " , and failing to forward the form to S11 RN Director of ED/ATC, which resulted in the incident not being investigated.
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, record review, and interview the hospital failed to ensure that the patient had the right to make Informed decisions regarding Blood/Blood product transfusions as evidenced by failing to ensure there was documented evidence of an Informed Consent for Blood/Blood Product transfusion on the medical record for blood administration in accordance with the hospital's policy and procedure for 1 of 31 sampled patients (#11) and 4 of 5 focused sampled patients for Blood/Blood product administration. (#9, #R1, #R2, #R7) Findings:

Patient #11

Review of the medical record of patient #11 revealed the patient was administered 1 unit of Packed Red Blood Cells (PRBC ' s) on 11/03/11 and 1 unit of Platelets on 11/09/11.

Review of a document titled "Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgement of Receipt of Medical Information" (not documented as completed until the Blood Product Transfusion on 11/09/12, 6 days after the transfusion of one unit of Packed Red Blood Cells (PRBC's) on 11/03/12) revealed the following: "Information About the Document - Read Carefully Before Signing. To the patient: You have been told that you should consider medical treatment/surgery. Louisiana law requires us to tell you (1) the nature of your condition, (2) the general nature of the medical treatment/surgery, (3) the risks of the proposed treatment/surgery, as defined by the Louisiana Medical Disclosure Panel or as determined by your doctor, (4) reasonable therapeutic alternatives and material risks associated with such alternatives, and (5) risks of no treatment. You have the right, as a patient, to be informed about your condition and the recommended surgical, medical or diagnostic procedure to be used so that you may make the decision whether or not to undergo the procedure after knowing the risks and hazards involved. In keeping with the Louisiana law of informed consent, you are being asked to sign a confirmation that we have discussed all these matters. We have already discussed with you the common problems and risks. We wish to inform you as completely as possible. Please read the form carefully. Ask about anything you do not understand, and well [sp?] will be pleased to explain. 1. Patient name: (last name of patient #11). 2. Treatment/Procedure: (a) ...Infusion of Blood and/or Blood Products. (b) Purpose: To correct a low blood count. 3. Patient's Condition: Patient's diagnosis, description of the nature of the condition or ailment for which the medical treatment, surgical procedure or other therapy described in item number 2 is indicated and recommended: (blank). Material Risks of treatment procedure: All medical or surgical treatment involves risks. Listed below are those risks associated with this procedure that we believe a reasonable person in you [sp?} (the patient's) position would likely consider significant when deciding whether to have or forego the proposed therapy. Please ask your physician if you would like additional information regarding the nature or consequences of these risks, their likelihood of occurrence, or other associated risks that you might consider significant but may not be listed below. (check box - not marked) See attachment for risks identified by the Louisiana Medical Disclosure Panel. (check box - not checked) See attachment for risks determined by your doctor. Additional risks, if any, particular to the patient because of a complicating medical condition are: (blank) ...6. Acknowledgement - Authorization and Consent. (a) No Guarantees: All information given to me and, in particular, all estimates made as to the likelihood of occurrence of risks of this or alternate procedures as to the prospects, are made in the best professional judgment of my physician. The possibility and nature of complications cannot always be accurately anticipated and therefore, there is and can be no guarantee, either express or implied, as to the success or other results of the medical or surgical procedure. (b) Additional Information: Nothing has been said to me, no information has been given to me, and I have not relied upon any information that is inconsistent with the information set forth in this document. (c) Particular concerns: I have had an opportunity to disclose and discuss with the physician providing such information, those risks or other potential consequences of the medical treatment or surgical procedures that are of particular concern to me. (d) Questions: I have had the opportunity to ask and I have asked questions I may have about the information in this document and any other questions I have about the proposed treatment of procedure and all such questions were answered in a satisfactory manner. (e) Authorized Physician: The physician (or physician group) authorized to administer or perform the medical treatment, surgical procedures or other therapy described in item 2 is: (Name of authorized physician or group)._______ (line is blank). (f) Physician Certification: I hereby certify that I have provided and explained the information set forth herein, including any attachment, and answered all questions of the patient, or the patient ' s representative, concerning the medical treatment or surgical procedure to the best of my knowledge and ability. __________ Signature of Physician or Certified Registered Nurse Anesthetist. Date/Time. (line is blank). CONSENT. Consent: I hereby authorize and direct the designated authorized physician/group, together with associates and assistants of his choice, to administer or perform the medical treatment or surgical procedure described in item 2 of this Consent Form, including any additional procedures or services as they may deem necessary or reasonable ...I (do) (do not) (neither choice is marked) consent to the use of blood and blood products, as deemed necessary. I have read and understand all information set forth in this document, including all attachment(s), and all blanks were filled in prior to my signing. This authorization for and consent to medical treatment or surgical procedure is and shall remain valid until revoked. I acknowledge that I have had the opportunity to ask questions about the contemplated medical procedure or surgical procedure described in item 2 of this consent form, including risks and alternatives, and acknowledge that my questions have been answered to my satisfaction." The document is witnessed by S6 RN dated 11/09/11 at 1510 (3:10 p.m.) and by (patient #11) dated/timed 11/09/11 at 1510 (3:10 p.m.).

Review of a document attached to the above consent form is a document titled: "Material Risks Identified by the Louisiana Medical Disclosure Panel" that revealed: "Patient Name: (patient #11). Procedure: Blood and Blood Components; Transfusion of. Material Risks: 1. Fever. 2. Transfusion Reaction which may include kidney failure or anemia. 3. Heart failure. 4. Hepatitis. 5. AIDS (acquired immune deficiency syndrome). 6. Other infections. Signature of Physician______ (line is blank). Witness: S6RN, dated/timed 11/09/10 (wrong year) at 1510 (3:10 p.m.). Patient or Person Authorized to Consent: 11/09/10 (wrong year) at 1510 (3:10 p.m.)."

Review of a document titled "Ambulatory Treatment Center (ATC) - Transfusion Orders" revealed the following: "Date: 11/3/11. Time: 8:00. 1. Admit to ATC as Outpatient. 2. Diagnosis: (ICD-9 codes 285.9, 157.0, 1552). 3. Diet as tolerated. 4. Vital signs per transfusion protocol. 5. Pre Lab Results: HgB (hemoglobin) 7.9, Hct (Hematocrit), 24.3. 6. Type and match for: (check box) Packed RBC's 1 unit ...7. Pre-medicate with: Tylenol 650 mg (milligrams) 1 po (by mouth), Decadron 20 mg 1 IV (intravenously), Pepcid 20 mg 1 IV, and Benadryl 25 mg 1 IV." (all 4 of the listed medications are marked X (times) 1 prior to 1st transfusion." The "Physician Signature" line is signed by S12MD.

Review of a document titled "Blood Bank Issue Transfusion Record revealed the following: "...Patient: (patient #11)...Ordering Doctor: (S12MD)...Product: RBC LR Aph 2 (Red Blood Cells Leukocyte Reduced Apheresis)...Transfusion Record. Before starting the transfusion, 2 nurses verify the following information: 1) Pt's name, MR# (medical record number), and BB (blood band) ID# on the Issue Transfusion Record matches the pt armbands. 2) Unit # (blood product) and unit ABO (The ABO blood group system is the most important blood type system (or blood group system) in human blood transfusion. Wikipedia.) and Rh type are the same on the Issue Transfuse Record and the Blood Bag. Transfusionist (signed by S5RN. Witnessed by S6RN. Transfusion Started: 11/03/11 at 1410 (2:10 p.m.)."

Further review of the documented Vital Signs for 11/03/11 during the Transfusion of Blood Products revealed the following vital signs were documented: "11/03/11 at 1410 (2:10 p.m.) (at the documented time of starting the Transfusion), 11/03/11 at 1535 (1 hour and 25 minutes after the documented start of the Transfusion), and 11/03/11 at 1600 (4:00 p.m.) (the time documented as "transfusion Completed.")

Review of the entire medical record for patient #11 revealed no Consent for Transfusion of Blood Products or Material Risks Identified by the Louisiana Medical Disclosure Panel prior to 11/09/11.

Review of a document titled "Ambulatory Treatment Center (ATC) - Transfusion Orders" revealed the following: "Date: 11/9/11. Time: 11:45. 1. Admit to ATC as Outpatient. 2. Diagnosis: (ICD-9 codes 287.4). 3. Diet as tolerated. 4. Vital signs per transfusion protocol. 5. Pre Lab Results: HgB (hemoglobin) 9.1, Hct (Hematocrit), 24.3. 6. Type and match for: (check box) Platelets 1 unit ...7. Pre-medicate with: Tylenol 650 mg (milligrams) 1 po (by mouth), Decadron 20 mg 1 IV (intravenously), Pepcid 20 mg 1 IV, and Benadryl 25 mg 1 IV. " (all 4 of the listed medications are marked X (times) 1 prior to 1st transfusion." The "Physician Signature" line is signed by S12MD.

Review of a document titled "Blood Bank Issue Transfusion Record revealed the following: "...Patient: (patient #11)...Ordering Doctor: (S12MD) ...Product: Plt LR Aph (Platelet Leukocyte Reduced Apheresis)...Transfusion Record. Before starting the transfusion, 2 nurses verify the following information: 1) Pt's name, MR# (medical record number), and BB (blood band) ID# on the Issue Transfusion Record matches the pt armbands. 2) Unit # (blood product) and unit ABO (The ABO blood group system is the most important blood type system (or blood group system) in human blood transfusion. Wikipedia.) and Rh type are the same on the Issue Transfuse Record and the Blood Bag. Transfusionist (signed by S6RN). Witnessed by S17RN. Transfusion Started: 11/09/11 at 1330 (1:30 p.m.)."

Further review of the documented Vital Signs for 11/09/11 during the Transfusion of Blood Products revealed the following vital signs were documented: "11/09/11 at 1330 (1:30 p.m.) (at the documented time of starting the Transfusion), 11/09/11 at 1345 (15 minutes after the documented start of the Transfusion), 11/09/11 at 1415 (2:15 p.m.) (30 minutes after the documented start of the Transfusion) and 1440 (2:40 p.m.) (the time documented as "transfusion Completed.")

In an interview on 03/8/12 at 11:36 a.m. with S6RN she stated she witnessed the Blood Consent and Material Risk forms for patient #11 on 11/09/11 at 1510 (3:10 p.m.). S6RN confirmed she signed the Transfusion Record as the RN witness on 11/03/11 for the PRBC's administered to patient #11, 6 days prior to the Blood Consent and Material Risks form being signed by patient #11. S6RN further confirmed that she signed the Transfusion Record as the transfusionist on 11/09/11 for the Platelets administered to patient #11 on 11/09/11, the day the consent was signed by patient #11 with no physician signature. S6RN confirmed there was no physician signature on the consent. S6RN further stated that she is aware of the hospital policy NR-2-6-001 and NR-2-6-020.

In an interview on 03/07/12 at 2:00 p.m. with S1VP Clinical Services she stated that the Blood Transfusion Consent for patient #11 was incomplete and that neither the PRBC's (on 11/03/12) or Platelets transfused (on 11/09/12) to patient #11 should have been administered. S1VP Clinical Services also presented a revised version of the "Ambulatory Treatment Center: Transfusion Orders" , revised 02/2012 that now included the following: "8. Transfuse _______units PRBC's on ________ (date). 9. Transfuse ________units Platelets on ________ (date)."

On 03/08/12 at 12:30 p.m. the sample was expanded to include the 5 (five) most recent medical records for patients receiving Blood or Blood Products on the ATC. The following records were reviewed. (#9, #12, #R1, #R2, #R3) In addition an observation was made on the ATC on 03/08/12 at 1:05 p.m. where one (#R7) patient was receiving Blood.

Patient # 9

Review of the Blood and/or Blood Product Consent revealed: "...2.a. Description, nature, benefits of the treatment/procedure: Blank ...8.f. Physician Certification: I hereby certify that I have provided and explained the information set forth herein, including any attachment, and answered all questions of the patient, or the patient's representative, concerning the medical treatment or surgical procedure, to the best of my knowledge and ability. Signature of Physician. (Blank). Date/Time: (Blank) ...CONSENT ...I have read and understand all information set forth in this document, including any attachment(s), and all blanks were filled in prior to my signing ..." The document is witnessed by S17RN on 03/06/12 at 8:30 a.m. and signed by patient #9 on 03/06/12 at 8:30 a.m.

Review of the "Material Risks Identified by The Louisiana Medical Disclosure Panel" revealed it was witnessed by S17RN on 03/06/12 at 8:30 a.m. and signed by patient #9 on 03/06/12 at 8:30 a.m. Further review revealed no physician's signature on the document.

Patient #R1

Review of the Blood and/or Blood Product Consent revealed: "...2.a. Description, nature, benefits of the treatment/procedure: Blank ...8.f. Physician Certification: I hereby certify that I have provided and explained the information set forth herein, including any attachment, and answered all questions of the patient, or the patient's representative, concerning the medical treatment or surgical procedure, to the best of my knowledge and ability. Signature of Physician. (Blank). Date/Time: (Blank) ...CONSENT ...I have read and understand all information set forth in this document, including any attachment(s), and all blanks were filled in prior to my signing ..." The document is witnessed by S7RN on 03/06/12 at 8:10 a.m. and signed by patient #R1 on 03/06/12 at 8:10 a.m.

Review of the "Material Risks Identified by The Louisiana Medical Disclosure Panel" revealed it was witnessed by S6RN on 03/06/12 at 8:30 a.m. and signed by patient #R1 on 03/06/12 at 8:30 a.m. Further review revealed no physician's signature on the document.
In an interview on 03/08/12 at 1:20 p.m. with S7RN she confirmed that the Blood Product Consent and the Material Risks From were not signed by the physician.

Patient #R2

Review of the Blood and/or Blood Product Consent revealed: "...2.a. Description, nature, benefits of the treatment/procedure: Blank ...8.f. Physician Certification: I hereby certify that I have provided and explained the information set forth herein, including any attachment, and answered all questions of the patient, or the patient's representative, concerning the medical treatment or surgical procedure, to the best of my knowledge and ability. Signature of Physician. (Blank). Date/Time: (Blank) ...CONSENT ...I have read and understand all information set forth in this document, including any attachment(s), and all blanks were filled in prior to my signing ..." The document is witnessed by S7RN on 03/07/12 at 10:25 a.m. and signed by patient #R2 on 03/07/12 at 10:25 a.m.

Review of the "Material Risks Identified by The Louisiana Medical Disclosure Panel" revealed it was witnessed by S7RN on 03/06/12 at 8:30 a.m. and signed by patient #R2 on 03/06/12 at 8:30 a.m. Further review revealed no physician's signature on the document.

In an interview on 03/08/12 at 1:20 p.m. with S6RN she confirmed that the Blood Product Consent and the Material Risks From were not signed by the physician.

Patient #R7 (observation on the ATC on 03/08/12 at 1:05 p.m.)

In an observation made on the ATC on 03/08/12 at 1:05 p.m. it was noted that one patient was receiving Blood. S6RN and S7RN were on duty on the unit. S1VP Clinical Services accompanied the surveyor's to the unit.

Patient # R7 was on the unit and was receiving PRBC's via her Medi-Port.

Review of the Blood and/or Blood Product Consent revealed: "...2.a. Description, nature, benefits of the treatment/procedure: Blank ...8.f. Physician Certification: I hereby certify that I have provided and explained the information set forth herein, including any attachment, and answered all questions of the patient, or the patient's representative, concerning the medical treatment or surgical procedure, to the best of my knowledge and ability. Signature of Physician. (Blank). Date/Time: (Blank) ...CONSENT ...I have read and understand all information set forth in this document, including any attachment(s), and all blanks were filled in prior to my signing ..." The document is witnessed by S17RN on 03/02/12 at 8:13 a.m. and signed by patient #R7 on 03/02/12 at 8:13 a.m.

Review of the "Material Risks Identified by The Louisiana Medical Disclosure Panel" revealed it was witnessed by S17RN on 03/02/12 at 8:13 a.m. and signed by patient #R7 on 03/02/12 at 8:13 a.m. Further review revealed no physician's signature on the document.
In an interview on 03/08/12 at 1:20 p.m. with S6RN and S7RN both confirmed that the Blood Product Consent and the Material Risks From were not signed by the physician.

In an interview at the time of observation (03/08/12 at 1:05 p.m.) S6RN confirmed that the order set being used for patient #R7 did have an order to Type and Match for 2 units of PRBC's, but contained no order to transfuse.

In an interview at the time of observation (03/08/12 at 1:05 p.m.) S7RN confirmed that the order set being used for patient #R7 did have an order to Type and Match for 2 units of PRBC's, but contained no order to transfuse. S7RN stated she "assumed there was." S7RN further stated that it was "routine here to give blood with no physicians signature on the consent."

In an interview on 03/08/12 at 1:03 p.m. S1VP Clinical Services presented a document with the following documentation: "ATC meeting with following physicians: (S10MD) - Feb. 3, 2012 at 1pm. (S12MD) - Feb. 10, 2012 at 0900 (9:00 a.m.). Issues addressed: New Transfusion Order Set. Blood Consent Requirements..." S1VP Clinical Services stated that this document was prepared by S11RN, Director of ATC, on 03/07/12. S1VP Clinical stated S11RN was not available for interview.

In an interview on 03/09/12 with S12MD at 8:35 a.m. he stated he discusses the lab work (Hemoglobin and Hematocrit) and the need for Blood Transfusion with his patients in his office. S12MD further stated he explains the risks and benefits with the patients in his office. S12MD stated he has not been sending a signed "Consent for Blood Products" to the hospital with the patient. S12MD confirmed the "Transfusion Order" sheet used by the hospital prior to 02/12 and the "Transfusion Order" sheet sent by his office (for the transfusion in progress) on patient #R7 did not contain a specific order to transfuse Blood to the patient. S12MD stated he would expect nurse's to call for clarification if orders were not clear. S12MD stated that prior to the morning of his interview with surveyor's (03/08/12) he had never seen the "new" order set presented to the surveyor's.

In an interview on 03/09/12 at 9:32 a.m. with S10 MD he stated he was not aware of issues with consent forms not being signed by the physician or the hospital policy indicating a physician signature was needed. S10MD stated he was not "the institute administering the blood and I am not responsible for consent." He further stated that consent was done by the nurse at the ATC. S10MD further stated that the re-education the hospital documented as taking place on Feb. 3rd, 2012 "never occurred."

In a telephone interview on 03/09/12 at 9:41 a.m. with S13Chief Medical Officer (CMO) he stated it was up to the attending physician to consent the patient. He further stated that "if the physician is ordering blood the physician should perform the Informed Consent."

Review of a hospital policy titled "Blood Transfusion Procedure", policy number NR-2-6-001, issue date: 04/88, last revised 05/11, presented as current hospital policy, read in part: "Standard of Care. The patient can expect to receive compatible blood for transfusion and be monitored for possible reactions allowing for privacy in a safe and competent manner. Standard of Practice. The RN (Registered Nurse) will administer blood products in a safe and competent manner and allow for patient's privacy. Designated Personnel: RN ...Procedure: I. Verify physician's order ...IV. B. The Consent and Material Risk Form is signed by the patient and doctor and placed in the patient's chart. The administration of the blood product is not to occur until the consent is signed. In the event the physician is unavailable, such as night time, the Consent and Material Risk form will be dated, timed, and signed by the physician/LIP (licensed independent practitioner within 24 hours ...VIII. Place order to TRANSFUSE in the computer system when you are ready to hang blood ...1. Verify that a Consent Form has been signed by the patient and doctor and is on the chart. 2. Verify that a MATERIAL RISKS OF TRANSFUSION has been signed by the patient and doctor and is on the chart ...X. Obtain vital signs. Record on the Blood Transfusion Flow Sheet: A. The flow sheet MUST STAY ATTACHED TO THE UNIT until completion of transfusion ...1. This will serve as baseline in case the patient has adverse reaction. 2. Vital signs should be taken at the following intervals. a. Prior to transfusion-baseline. b. 15 minutes after start of transfusion. c. Every 30 minutes for duration of transfusion. d. At completion of transfusion. e. One hour post transfusion ..."

Review of a hospital policy titled "Platelet Transfusion Procedure/Care of Patient", policy number NR-2-6-020, issued 04/88, revised/approved date: 05/11, presented as current hospital policy, reads in part: "Standard of Care: The patient/caregiver can expect the patient to receive appropriate platelet infusion or bolus and be monitored privately for possible reactions. Standard of Practice: The RN will administer platelets in a safe, private and competent manner ...Procedure. I. Verify physician's order. I ...b. Verify education and consent forms are on chart. The administration of blood product is not to occur until the consent is signed. In the event the physician is unavailable, such as night time, the Consent and Material Risk form will be dated, timed, and signed by the physician/LIP within 24 [hours]. VII. Obtain vital signs. Record on the Blood Transfusion Flow Sheet: A. The flow sheet MUST STAY ATTACHED TO THE UNIT until completion of transfusion ...1. This will serve as baseline in case the patient has adverse reaction. 2. Vital signs should be taken at the following intervals. a. Prior to transfusion-baseline. b. 15 minutes after start of transfusion. c. Every 30 minutes for duration of transfusion. d. At completion of transfusion. e. One hour post transfusion ..."

Review of a hospital policy titled "Informed Consent", policy number RI-A-030, issued January 15, 1997, last revised 11/11, presented as current hospital policy, revealed: "General Statement. It is our belief that persons have the right to be involved in all aspects of their care. The purpose of this policy is twofold: 1) to insure that a patient's right to be informed and to participate in decision-making is protected and defined, and 2) to insure compliance with applicable federal and state statutes and other regulating bodies. Policy: A. Consent is the voluntary agreement of a person with decision making capacity to make an intelligent choice to do something proposed by another. Informed consent to medical treatment means a consent in writing to any medical or surgical procedures or course of procedures which: 1. Sets forth in general terms the nature of the procedure or procedures, together with known risks...2. Acknowledges that such disclosure of information has been made...3. is signed by the patient for whom the procedure is to be performed...Informed consent is not merely obtaining a signed document. It is an ongoing process that considers the patient's needs and preferences, compliance with institutional policies, the law...B. As a fundamental aspect of the physician/patient relationship and before a patient gives his consent, the physician who will actually perform the medical or surgical procedure must clearly explain to the patient ...the following: Source: La. Rev. Stat. Ann. 40:1299.40(A)(1). 1. Nature of pertinent ailment or condition and general nature of proposed treatment or procedure. 2. Potential benefits and known risks...5. Possible results of non-treatment. 6. Risks and benefits of any reasonable therapeutic alternatives...C. A consent form will be completed and executed by the patient or the patient's health care decision maker prior to the performance of any procedures listed in the Louisiana Medical Disclosure Panel's procedures that require Disclosure...E. Surgical and/or Special Consent Forms. These completed forms should be used for the following:..6. When the treating physician determines that the patient will require transfusion(s) of blood and/or blood products...K. Documenting the Consent Given:..4. The names, both of the person giving consent and of those who heard it, must be documented in the medical record ...Informed Consent:..3. The attending physician is responsible for verifying the validity of the consent form. This responsibility is not delegated or alleviated by nursing staff documenting the physician's consent conference with the patient by obtaining the patient's signature on the hospital consent form ..."

Review of LA R.S. ?1299.40 revealed the following:

PART XXII. UNIFORM CONSENT LAW

?1299.40. Consent to medical treatment; exception; Louisiana Medical Disclosure Panel; availability of lists to establish necessity and degree. A.(1) Notwithstanding any other law to the contrary, written consent to medical treatment means a handwritten consent to any medical or surgical procedure or course of procedures which: sets forth in general terms the nature and purpose of the procedure or procedures, together with the known risks, if any, of death, brain damage, quadriplegia, [DIAGNOSES REDACTED], the loss or loss of function of any organ or limb, of disfiguring scars associated with such procedure or procedures; acknowledges that such disclosure of information has been made and that all questions asked about the procedure or procedures have been answered in a satisfactory manner; and is signed by the patient for whom the procedure is to be performed, or if the patient for any reason lacks legal capacity to consent by a person who has legal authority to consent on behalf of such patient in such circumstances. Such consent shall be presumed to be valid and effective, in the absence of proof that execution of the consent was induced by misrepresentation of material facts ...B. Except as provided in Subsection A of this Section, no evidence shall be admissible to modify or limit the authorization for performance of the procedure or procedures set forth in such written consent. C. Where consent to medical treatment from a patient, or from a person authorized by law to consent to medical treatment for such patient, is secured other than in accordance with Subsection A above, the explanation to the patient or to the person consenting for such patient shall include the matters set forth in Paragraph (1) of Subsection A above, and an opportunity shall be afforded for asking questions concerning the procedures to be performed which shall be answered in a satisfactory manner. Such consent shall be valid and effective and is subject to proof according to the rules of evidence in ordinary cases (b) Consent to medical treatment may be evidenced according to the provisions of Subsections A and C of this Section or, as an alternative, a physician or other health care provider may choose to avail himself of the lists established by the Louisiana Medical Disclosure Panel pursuant to the provisions of this Subsection as another method by which to evidence a patient's consent to medical treatment ...(3)(a) The Louisiana Medical Disclosure Panel is created within the Department of Health and Hospitals to determine which risks and hazards related to medical care and surgical procedures must be disclosed by a physician or other health care provider to a patient or person authorized to consent for a patient and to establish the general form and substance of such disclosure ...(b) The panel shall prepare separate lists of those medical treatments and surgical procedures that do and do not require disclosure and for those treatments and procedures that do require disclosure shall establish the degree of disclosure required and the form in which the disclosure will be made ...(c) Lists prepared under Subparagraph 4(b) of this Subsection together with written explanations of the degree and form of disclosure shall be promulgated according to the Administrative Procedure Act. The form of the disclosure and manner in which such disclosure will be made shall be subject to legislative oversight by the House and Senate Health and Welfare Committees. The initial lists of the panel shall be published on or before January 1, 1991, or at such time as soon after that date as the panel determines to be feasible, but, in no event, shall the initial lists be published later than March 1, 1991. The lists compiled and published and rules promulgated relative to the form and manner of disclosure according to the provisions of this Subsection and evidence of such disclosures or failure to disclose by a physician or other health care provider as provided in Paragraphs (5) and (6) of this Subsection, shall be admissible in a health care liability suit or medical malpractice claim involving medical care rendered or a surgical procedure performed on or after March 1, 1991 ...(5) Before a patient or a person authorized to consent for a patient gives consent to any medical or surgical procedure that appears on the panel's list requiring disclosure, the physician or other health care provider shall disclose to the patient, or person authorized to consent for the patient, the risks and hazards involved in that kind of care or procedure. A physician or other health care provider may choose to utilize the lists prepared by the panel and shall be considered to have complied with the requirements of this Subsection if disclosure is made as provided in Paragraph (6) of this Subsection ...(6) Consent to medical care that appears on the panel's list requiring disclosure shall be considered effective under this Subsection, if it is given in writing, signed by the patient or a person authorized to give the consent and by a competent witness, and if the written consent specifically states, in such terms and language that a layman would be expected to understand, the risks and hazards that are involved in the medical care or surgical procedure in the form and to the degree required by the panel under Paragraph (4) of this Subsection ...(7)(a) In a suit against a physician or other health care provider involving a health care liability or medical malpractice claim which is based on the negligent failure of the physician or other health care provider to disclose or adequately to disclose the risks and hazards involved in the medical care or surgical procedure rendered by the physician or other health care provider: (i) Both the disclosure made as provided in Paragraph (5) of this Subsection and the failure to disclose based on inclusion of any medical care or surgical procedure on the panel's list for which disclosure is not required shall be admissible in evidence and shall create a rebuttable presumption that the requirements of Paragraphs (5) and (6) of this Subsection have been complied with and this presumption shall be included
VIOLATION: PATIENT RIGHTS: ADMISSION STATUS NOTIFICATION Tag No: A0133
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview, record review and policy review, the hospital failed ensure patients were being informed of their admission status as evidenced by failing to follow the Admission Criteria policy for 1 of 31 patients (#4). Findings:


Record review of Policy Number CC-A-060 titled "Admission and Discharge Criteria" revised 1/12 (pg 1 of 1) revealed under Procedure II.A. "The current criteria utilized is "InterQual"...and is considered a part of and is appended to the Case Management Plan." Under Procedure I. A. 1. "Documentation within the medical record must meet established inpatient criteria in order for the Case Manager to validate the medical necessity of the admission. 2. Observation stays can be validated when established observation criteria is documented."

During an interview on 03/08/12 from 9:20 a.m. to 9:35 a.m., S26RN ED indicated she faxed patient #4 ' s face sheet and physician ' s orders (Acute Coronary Syndrome) to S27 RN Patient Access Coordinator (PAC) nurse so the PAC nurse can determine whether the patient ' s condition meets criteria for admission (either inpatient or observation). S26RN ED indicated it is the physician in the emergency department who notifies the patient of their admission status prior to admitting them into the hospital.

Review of the " Acute Coronary Syndrome Physician Orders " dated/timed 04/30/11 at 2:30 p.m. (1430) by S18MD ED revealed the patient (#4) was admitted to S22Primary Care Physician with the diagnosis of chest pain for an observation status. The " Observation " status had a circle drawn around the word and the " Inpatient " status was scratched out on the form.
In an interview on 03/07/12 at 3:55 p.m. and at 4:35 p.m., the Director of ED (S11) verified the " Acute Coronary Syndrome Admission Orders " by S18MD ED had inpatient scratched out on the form and outpatient was circled indicating the patient ' s admission status was outpatient/observation on 04/30/11. S11 indicated the PAC nurse (S27RN) is consulted as per the physician orders to determine what the patient ' s admission status is based on the specific criteria guidelines. S11Director of ED verified the nurses ' notes dated 04/30/11 revealed " faxed " with S26RN ED ' s initials noted and no date/time and what was faxed and to who/whom. The ED nurse faxes the physician's orders to the PAC nurse who reviews the admission criteria for the patient. The PAC nurse (S27RN) usually notifies the physician in the emergency department of the patient ' s admission status prior to the patient being admitted . S11Director of ED indicated the physician in the emergency department is expected to notify the patient of the admission status of inpatient and/or outpatient/observation prior to admitting the patient into the hospital.

In an interview on 03/08/12 from 8:20 a.m. through 8:50 a.m., S18ED MD verified the " Acute Coronary Syndrome Admission Orders " dated/timed 04/30/11 at 2:30 p.m. (1430) had the patient ' s (#4 ' s) admit status of inpatient scratched out on the form and the admit status of outpatient was circled. S18ED MD indicated the patient (#4) was admitted to the unit, 41 on 04/30/11 as an outpatient/observation status. S18MD reported the PAC nurse (S27RN) determines what the admission status of the patient is. The PAC nurse (S27RN) determines the patient ' s admission status regarding what the payer source criteria is. S18MD ED indicated he never discusses the patient ' s admission status of inpatient and/or observation because he does not know the difference between the two. S18MD ED denied informing Patient #4 and/or his family members of his admission status change from inpatient to outpatient/observation status because he did not know enough about it to explain the differences to the patients and/or family members. S18MD ED did not know who was to explain what the patient ' s admission status of inpatient and/or observation to the patients admitted from the emergency department to the unit. S18MD ED indicated there is a system failure regarding who and/or whom informs the patient ' s (#4 ' s) of their admission status of inpatient and/or observation status.

An interview was conducted on 03/08/12 from 9:30 a.m. through 9:50 a.m. with S27RN, Patient Access Coordinator (PAC). S27RN, PAC indicated the " InterQual Level of Care Criteria 2011 " is used to determine the admission status of observation and/or inpatient for patients. This index criterion is condition/diagnosis specific for " ACS " (Acute Coronary Syndrome) to determine whether or not the patient (#4) qualifies for observation and/or inpatient status. The information under the ACS index is compared with the physician ' s , (S18MD ED) " Acute Coronary Syndrome Orders " dated/timed 04/30/11 at 2:30 p.m. (1430) with the diagnosis of chest pain, the patient ' s lab work, " Troponin-1 " , the patient ' s ECG readings dated 04/30/11 and vital sign readings on 04/30/11 at 12:49 p.m. (1249). S27RN verified the physician orders, ECG, lab work and blood pressure readings in the patient ' s (#4 ' s) medical record with the index criteria for Acute Coronary Syndrome during this interview as follows: the physician, S18MD ED wrote the Acute Coronary Syndrome Orders dated timed 04/30/11 at 2:30 p.m. (1430). The initial cardiac biomarkers negative (the Troponin-1 lab results on 04/30/11 and 05/01/11 were both negative). ECG was unchanged (normal sinus rhythm, pacemaker). Systolic BP baseline or >90 mmHG (132/82). Aspirin administered (physician ordered ASA 325 mg chewed NOW then Aspirin 325 mg 1 po daily and continue at discharge). Continuous cardiac monitoring (telemetry was ordered by the physician) ... " . S27RN PAC indicated the patient (#4) was assigned an observation status upon his admission into the hospital on [DATE] as per the " Acute Coronary Syndrome, Admission " criteria used for all Medicare patients. S27RN PAC further indicated the patient (#4) admission status of observation was followed as per the Medicare InterQual Level of Care Criteria 2011 for Acute Coronary Syndrome Admission guidelines during his hospital stay from 04/30/11 through 05/02/11. S27RN verified the " Acute Coronary Syndrome Admission Orders " by S18MD ED had inpatient scratched out on the form with outpatient circled. S27PAC nurse denied knowledge of whether or not she had informed the physician (S18MD ER) that the patient ' s admission status was changed from inpatient to observation/outpatient prior to the patient being admitted to the unit room " a " on 04/30/11. S27PAC nurse indicated she usually documents her Medicare diagnosis specific review for admission criteria on PAC notes. S27PAC further indicated she did not have her PAC notes indicating the date, time, and physician that she notified the physician (S18MD ED) of the patient ' s (#4 ' s) admission status after the Medicare diagnosis specific admission criteria was reviewed on 04/30/11 and/or 05/01/11.

In an interview on 03/08/12 from 11:20 a.m. to 11:26 a.m., S4Case Manager verified Patient #4 ' s admission status of observation was determined by the PAC nurse (S27RN) upon admission on 04/30/11 as per the Medicare specific diagnosis criteria for Acute Coronary Syndrome. S4Case Manager indicated the physician determines what the patient ' s admission status is. S4 continued the physician consults the PAC nurse to determine what the admission status of the patient (#4) is based on the patient ' s payer source. The PAC nurse notifies the ED physician usually prior to the patient (#4) being transferred from the emergency department to the unit of what the patient ' s admission status of inpatient and/or observation. The ED physician usually changes the admission status on the " Admission Orders " from inpatient to outpatient and/or observation status prior to transferring the patient to the unit. S4Case Manager verified S18MD ED ' s Admission Orders dated/timed 04/30/11 at 2:30 p.m. (1430) had inpatient scratched out on the form with outpatient circled. S4 indicated the PAC nurse informed the ED MD that the patient ' s admission status was observation/outpatient rather than inpatient status prior to the patient being admitted to room " a " .

During an interview on 03/08/12 at 9:10 a.m. and on 03/09/12 at 12:45 p.m., S1VP (vice president) of Clinical Services verified S18MD ED admitted Patient #4 for " Observation " as indicated on the " Acute Coronary Syndrome Orders on 04/30/11 at 2:30 p.m. (1430). S1VP of Clinical Services confirmed the patient ' s (#4 ' s) admission status of observation was followed as per the " InterQual Level of Care Criteria 2011 " for " Acute Coronary Syndrome Admission Criteria " used for all Medicare patients during the hospital stay from 04/30/11 through 05/02/11. S1VP of Clinical Services verified the " Acute Coronary Syndrome Admission Orders " by S18MD ED dated/timed 04/30/11 at 2:30 p.m. (1430) had inpatient scratched out on the form and outpatient was circled. S1 indicated it is the admitting department ' s responsibility to notify the patient of their admission status. S1VP of Clinical Services denied knowledge that it is the responsibility of the physician to inform the patient of their admission status.

The hospital failed to identify the Admission criteria policy was not being followed as evidenced by S1, S4, S27, and S18 were unable to articulate who is responsible in notifying/informing patients of their admission status.
VIOLATION: PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT Tag No: A0145
Based on record review and interview the hospital failed to ensure the hospital had an effective policy to investigate allegations of abuse, have an abuse prohibition policy that covered staff on patient abuse, or conducted abuse prohibition training during orientation and reported allegations of abuse to DHH in accordance with the 24 hour reporting time frame (Louisiana Revised Statutes Title 40. Public Health and Safety Chapter 11. State Department of Health and Hospitals ?2009.2.), as evidenced by S32 entering the room of patient #20 in retaliation to a complaint filed with S8RN, Director Med/Surg, and verbally abusing her causing patient #20 to feel threatened, fear retaliation, and experience mental anguish. (#20) Findings:

Review of a hospital form titled "Problem Resolution for Complaints/Grievances" revealed the following: Name: (Patient #20). Date: 11/11/11. Taken by: S8RN, Director Med/Surg...Issue #1: The RN taking care of (patient #20) called me (S8RN) to ask if I would speak to a patient about an encounter she had with one of our employees. I met with (patient #20) in room "c". She stated that she was very upset with (S32), the tech who performed her EEG (electroencephalogram). She said that (S32) came into her room with her chart and proceeded to start reading medical reports out loud. (patient #20's) two sons were in the room and (S32) disclosed information that she did not want her sons to hear. (#20) said that (S32) proceeded to discuss the "awful details of her (S32) life" including incidents of "molestation and the day she put a gun to her head." (patient #20) was concerned about getting (S32) in trouble but, said this encounter upset her terribly and she didn't want another patient to go through what she went through."

Further review for Issue #1 revealed the following: "Proceedings taken on behalf of patient: (issue) #1: 11/11/11: I apologized profusely to (patient #20) and assured her that this transgression would would be addressed."

Review of the "Action Taken" for Issue #1 revealed: "11/11/11: I left a message with...manager of (S32) to call me as soon as possible. I learned later that he was out of the office until Tuesday, 11/15/11."

Review of the same form revealed "Issue #2 - The Charge Nurse (S14RN) called me (S8RN) and asked me to come to Unit 43 immediately to address threatening behavior from one of our associates toward a patient. When I (S8) went into (patient #20)'s room, she was crying and visibly upset. She stated that (S32)EEG Tech came in to her room this afternoon and pointed her finger at her and stated "Thanks for reporting me. Thanks to you, I'm going to lose my job." (patient #20) said that she felt very threatened and because of the nature of her conversation on Friday with (S32), afraid of retaliation."

Further review for Issue #2 revealed the following: "Proceedings taken on behalf of patient: (issue) #2: 11/14/11: Again, I apologized to (patient #20) and told her that we would assure her safety. We moved (patient #20) into another room that is closer to the Unit 43 nurse's station. She remains a confidential patient. Due to the serious nature of those complaints, (S32) was terminated and told that she would be escorted out if she returns to St. Patrick Hospital other than for medical reasons."

Review of the "Action Taken" for Issue #2 revealed: "11/14/11: I (S8RN) met with (S32) to discuss her inappropriate conversation with (patient #20) on Friday. I also discussed the fact that reading private information in front of a patient's family without their consent was a HIPPA violation. I informed (S32) that I would be discussing these concerns with her manager upon his return in the morning." Further review revealed documentation for "Action Taken - #3" that read: "11/14/11: We informed Security of (S32)'s threatening behavior. Along with (Human Resources personnel), (S32) was terminated over the phone. She was advised that if she came on campus for anything other than medical reasons, she would be escorted out by Security."

Review of an e-mail dated November 14, 2011 at 1:23 p.m. from S8RN, Director Med/Surg, to (S35) (supervisor of S32), copied to S1VP Clinical Services revealed: "(S35), I sent you an e-mail on Friday about some serious complaints about the EEG Tech, (S32). I received another phone call from a nurse on Unit 43 with more complaints. The nurse reported that the patient asked for something for pain and she (the nurse) replied that she couldn't have anything else at this time. (S32) interjected (in front of the patient) that she saw Percocet ordered on her chart and why couldn't she have this? This comment made the patient doubt the nurse's decision about managing her pain and shed an unfavorable light on the nurse. (S14RN), the Charge Nurse on Unit 43 said that she has asked (S32) in the past to refrain from making inappropriate comments in front of patients. Her reply was "I'll try but, I can't promise anything." I did address these concerns with (S32) today. She denied the complaint from the patient on Friday about reading reports in front of the patient's family. I also told her that under no circumstances was it appropriate to divulge inappropriate personal history (sexual molestation) with a patient. Her remark was "well she started the conversation." I told her that as a professional, it was up to her to keep her conversation professional and appropriate. She then stated that she saw it as her spiritual mission to help patients. I told her that the complaints I have received are very serious and that I would leave it up to you to address these complaints upon your return."

In an interview on 03/09/12 at 8:05 a.m. with S1VP Clinical Services she stated that when S32 entered the room of patient #20 on 11/14/11 that it was retaliation for reporting her (S32). S1VP Clinical Services stated that, according to the documentation by S8RN, patient #20 experienced mental anguish and feared retaliation. S1VP Clinical Services searched the hospital policy and procedure and stated that no policy defined abuse. She further stated that the incident as documented is abuse and further confirmed that a complete investigation was not done. S1VP Clinical confirmed that Louisiana Revised Statutes Title 40. Public Health and Safety Chapter 11. State Department of Health and Hospitals ?2009.20. Duty to make complaints; and it's associated requirement to report abuse to the Department of Health and Hospital's (DHH) within 24 hours was not followed. S1VP Clinical Services further stated she is "not aware of how to get that form." S1VP Clinical Services stated the hospital's current policy and procedure "does not address staff on patient abuse." She further stated that the hospital's "Associate Standards of Conduct" does not address the need to report abuse to DHH. S1VP Clinical Services stated that at the time of the investigation the hospital failed to identify the issue as abuse. She further stated that the hospital policy and procedure does not address the Investigation of abuse.

In a telephone interview on 03/09/12 at 10:25 a.m. with S8RN, Director of Med/Surg, she was asked if the behavior of S32 was abuse to which she replied "it is abusive behavior but the patient was not abused." The definition of abuse was read to S8RN. She then stated "by definition she thinks it was abuse." S8RN stated that S9 from Human Resources was involved in the termination of S32 and the grounds for termination were "inappropriate behavior."

In an interview on 03/09/12 at 10:42 a.m. with S1VP Clinical Services, S9Associate Relations Coordinator, and S33Director of Human Resources, S9 stated that she classified the incident by S32 as "Workplace Violence." S9 stated that she presented the information to her supervisor, S33, and both agreed this was "Workplace Violence." S9 and S33 stated the hospital has a policy regarding workplace violence and there is a zero tolerance policy which resulted in the termination of S32. Both also confirmed that S32 made "threatening comments" to S8RN. S9 and S33 stated that the incident report done by S8RN was used to investigate the incident, but added that Human Resources conducts the investigation and determines the outcome. S9 and S33 confirmed there is no hospital policy and procedure that delineates responsibilities when an allegation of abuse occurs, how to investigate, or who is responsible for reporting to DHH. During the same interview it was confirmed by S1VP Clinical Services, S9Associate Relations Coordinator, and S33Director of Human Resources that the hospital's orientation program does not address abuse prohibition.

Review of a hospital policy titled "Violence Free Workplace", Guideline No. 22.07, approved 07/20/10, revealed: "Objective: To maintain a safe work environment for patients, Associates, physicians, volunteers, visitors, and the public. Directive: Christus Health is committed to maintaining a violence-free workplace. Christus Health will not tolerate acts such as, but not limited to, intimidation, threatening or hostile behaviors, stalking, abuse...Procedure:..2. Associates who violate this guideline may be subject to disciplinary action, up to and including termination..."

Review of a hospital policy titled "Patient Rights and Responsibilities", policy number RI-A-010, issued June 1, 1994, revised 11/11, reads in part: "...Policy. In an effort to provide improved customer service and satisfaction, it is imperative that all parties involved in patient care, be knowledgeable regarding the rights and responsibilities of each patient, and the procedures for resolution of patient grievance. I. Patient Rights:...Q. To receive care in a safe setting, free from verbal or physical abuse or harassment..."

Review of hospital policy titled "Patient and Non-Patient Notification Reporting Procedure" policy number RM-A-002, issued 1/1/85, revised 5/11, reads under General Statement "A patient and non-patient notification are mechanisms for recording unusual or adverse events. Such reports describe incidents that are not consistent with the routine operation of the hospital or the routine care of a particular patient, or other customer." Under Policy, it reads "The statement of facts should be entered as descriptive as possible. It is important that the person involved or the one who witnessed the event complete the statement of facts (pg 1 of 2). Reportable agencies/final disposition will be completed by risk management (pg 2 of 2)."

Review of LA R.S. 40.?2009.2 revealed:

Louisiana Revised Statutes Title 40. Public Health and Safety Chapter 11. State Department of Health and Hospitals ?2009.2. Definitions (Excerpt) (3) "Department" shall mean the Department of Health and Hospitals...?2009.20. Duty to make complaints; penalty; immunity. A. As used in this Section, the following terms shall mean: (1) "Abuse" is the infliction of physical or mental injury or the causing of the deterioration of a consumer by means including but not limited to sexual abuse, or exploitation of funds or other things of value to such an extent that his health or mental or emotional well-being is endangered. (2) "Neglect" is the failure to provide the proper or necessary medical care, nutrition, or other care necessary for a consumer's well-being. B. (1) Any person who is engaged in the practice of medicine, social services, facility administration, psychological or psychiatric services; or any registered nurse, licensed practical nurse, nurse's aide, home- and community-based service provider employee or worker, personal care attendant, respite worker, physician's assistant, physical therapist, or any other direct caregiver having knowledge that a consumer's physical or mental health or welfare has been or may be further adversely affected by abuse, neglect, or exploitation shall, within twenty-four hours, submit a report to the department or inform the unit or local law enforcement agency of such abuse or neglect. When the department receives a report of sexual or physical abuse, whether directly or by referral, the department shall notify the chief law enforcement agency of the parish in which the incident occurred of such report. Such notification shall be made prior to the end of the business day subsequent to the day on which the department received the report. For the purposes of this Paragraph, the chief law enforcement agency of Orleans Parish shall be the New Orleans Police Department. (2) Any person who knowingly or willfully violates the provisions of this Section shall be fined not more than five hundred dollars or imprisoned for not more than two months, or both. C. Any person, other than the person alleged to be responsible for the abuse or neglect, reporting pursuant to this Section in good faith shall have immunity from any civil liability that otherwise might be incurred or imposed because of such report. Such immunity shall extend to participation in any judicial proceeding resulting from such report. D. All hospitals shall permanently display in a prominent location in their emergency room s a copy of R.S. 40:2009.20.
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**






Based on interview and policy review, the hospital failed (1) to track adverse patient events for 1 of 31 sampled patients and 0 of 7 random patients as evidenced by failing to investigate the complaint of a patient (#8) being hurt during a procedure by a nonhospital employee; and (2) failed to identify the Admission Criteria policy was not being followed as evidenced by 1 of 31 patients not being informed of their admission status (#4). Findings:

(1) Patient #8, a [AGE] year old female, entered the Emergency Department (ED) after a witnessed fall at a local bank. She arrived to the ED via an ambulance service. Patient #8 is currently receiving chemotherapy treatments for right-sided [DIAGNOSES REDACTED] post mastectomy. Her stated complaint at the time she entered the ED on 2/7/12 was left wrist pain and bilateral knee pain as a result from the fall.

Record review of Complete ED Record (pg 5 of 7) revealed documentation by S21 ED RN that S3 Service Guarantee Coordinator was in the ED talking to patient #8 about complaints of being hurt during IV insertion. S21 documented S20 Paramedic student had started the IV and it was very painful.

On 3/7/12 at 3:45 p.m. in an interview with S11 Director of ED/Adult Treatment Center (ATC) she stated the paramedic students are assigned a nurse preceptor. She added the nurse preceptor supervises any clinical skills a paramedic student performs.

On 3/8/12 at 10:30 a.m. in an interview with S3 Service Guarantee Coordinator, she stated she was called down to the ED when patient #8 was brought into the ED on 2/7/12. S3 stated patient #8 was upset because one of the paramedics who arrived at the site where patient #8 had fallen attempted to start an IV, which resulted in hurting patient #8. S3 stated as she was talking with the ED nurses at the nurses' station, a paramedic student came up to her and told her that patient #8 was upset with him (S20) because he tried to start an IV several times. S20 stated patient #8 was "flailing around" making it difficult to start an IV. S3 stated the incident of the painful IV was outside of the hospital, so she did not make an incident and/or grievance report. S3 stated since the incident occurred off the hospital grounds, she did not feel she needed to investigate the problem.

Record review of the Ambulance Service's Medical Record revealed no IV was initiated as an intervention on patient #8 on 2/7/12 when she fell at a bank and was transported to the ED.

On 3/9/12 at 9:05 a.m. in an interview with S24 Risk Manager for the Ambulance Service, he stated S20 Paramedic student was evaluated by a preceptor, S25 RN ED and he had good IV skills

On 3/9/12 at 9:15 a.m. in an interview with S25 RN ED, she confirmed she was S20 Paramedic Student's preceptor on 2/7/12 and 2/8/12. S25 stated as a preceptor, her responsibility was to help him with medication administration, airway management, and IV administration. S25 added she did not see S20 attempt to initiate an IV on patient #8 because patient #8 was not her assigned patient. S25 did observe S20 initiate an IV; yet, he was unsuccessful with one patient who was a dialysis patient.

On 3/9/12 at 10:30 a.m. in an interview with S28 RN ED, she confirmed she was the charge nurse on 2/7/12 in the ED. She remembers S20 Paramedic student. When asked if she supervised S20 when he attempted to initiate an IV on patient #8, S28 stated S20 had good IV skills, so no one had supervised him when he attempted to initiate the IV on patient #8. To her knowledge, S20 did not attempt more than once to start the IV on patient #8. She added no one had reported to her as the charge nurse that S20 had hurt patient #8 when he attempted to start the IV nor had patient #8 reported to S28 that she had told S20 to stop because the IV was painful.

Record review of Policy Number RI-A-180, revised dated 11/11, (pg 1 of 5) under General Statement reveals the hospital "will establish a process to assure timely response to concerns and complaints regarding care and service." Under I. Policy, "Complaints are investigated at the lowest organizational level possible." Under II. Customer Concerns or Complaints, Definition of Complaint/Concern is defined as "An expression of dissatisfaction with some aspect of care and/or service. Complaints will have simple and obvious causes that can be addressed promptly, by hospital staff, to the patient's satisfaction." Under III. Grievances, the Definition of Grievances is "A written or verbal complaint that has not been resolved prior to discharge by a patient, or the patient's representative, regarding the patient's care, abuse, or neglect, or the hospital's compliance with the Center for Medicare and Medicaid Services Hospital Conditions of Participation (COP). Examples of a grievance may include: Quality of Care."

Record review of policy titled "Patient and Non-Patient Notification Reporting Procedure" issue date 1/1/85, reviewed/revised date: 5/11, under General Statement reads "A patient and non-patient notification are mechanisms for recording unusual or adverse events. Such reports describe incidents that are not consistent with the routine operation of the hospital or the routine care of a particular patient, or other customer." Under Policy reads "The statement of facts should be entered as descriptive as possible. It is important that the person involved or the one who witnessed the event complete the statement of facts (pg 1 of 2). Reportable agencies/final disposition will be completed by risk management (pg 2 of 2).

Record review of policy titled "Patient Rights and Organizational Ethics Policy" Policy Number RI-A-180 issued 03/03/00; revised dated 11/11 revealed under Grievance Process 2. All grievances will be reported to the Grievance Committee and reported to the Board of Directors via the Quality Committee."

Record review of the Complaint/Grievance log revealed missing documentation of patient #8's complaint of being hurt by a nonhospital employee, which resulted in no investigation and no tracking of this incident/grievance.

(2) Record review of Policy Number CC-A-060 titled "Admission and Discharge Criteria" revised 1/12 (pg 1 of 1) revealed under Procedure II.A. "The current criteria utilized is "InterQual"...and is considered a part of and is appended to the Case Management Plan." Under Procedure I. A. 1. "Documentation within the medical record must meet established inpatient criteria in order for the Case Manager to validate the medical necessity of the admission. 2. Observation stays can be validated when established observation criteria is documented."

During an interview on 03/08/12 from 9:20 a.m. to 9:35 a.m., S26RN ED indicated she faxed patient #4 ' s face sheet and physician ' s orders (Acute Coronary Syndrome) to S27 RN Patient Access Coordinator (PAC) nurse so the PAC nurse can determine whether the patient ' s condition meets criteria for admission (either inpatient or observation). S26RN ED indicated it is the physician in the emergency department who notifies the patient of their admission status prior to admitting them into the hospital.

Review of the " Acute Coronary Syndrome Physician Orders " dated/timed 04/30/11 at 2:30 p.m. (1430) by S18MD ED revealed the patient (#4) was admitted to S22Primary Care Physician with the diagnosis of [DIAGNOSES REDACTED]" Inpatient " status was scratched out on the form.
In an interview on 03/07/12 at 3:55 p.m. and at 4:35 p.m., the Director of ED (S11) verified the " Acute Coronary Syndrome Admission Orders " by S18MD ED had inpatient scratched out on the form and outpatient was circled indicating the patient ' s admission status was outpatient/observation on 04/30/11. S11 indicated the PAC nurse (S27RN) is consulted as per the physician orders to determine what the patient ' s admission status is based on the specific criteria guidelines. S11Director of ED verified the nurses ' notes dated 04/30/11 revealed " faxed " with S26RN ED ' s initials noted and no date/time and what was faxed and to who/whom. The ED nurse faxes the physician's orders to the PAC nurse who reviews the admission criteria for the patient. The PAC nurse (S27RN) usually notifies the physician in the emergency department of the patient ' s admission status prior to the patient being admitted . S11Director of ED indicated the physician in the emergency department is expected to notify the patient of the admission status of inpatient and/or outpatient/observation prior to admitting the patient into the hospital.

In an interview on 03/08/12 from 8:20 a.m. through 8:50 a.m., S18ED MD verified the " Acute Coronary Syndrome Admission Orders " dated/timed 04/30/11 at 2:30 p.m. (1430) had the patient ' s (#4 ' s) admit status of inpatient scratched out on the form and the admit status of outpatient was circled. S18ED MD indicated the patient (#4) was admitted to the unit, 41 on 04/30/11 as an outpatient/observation status. S18MD reported the PAC nurse (S27RN) determines what the admission status of the patient is. The PAC nurse (S27RN) determines the patient ' s admission status regarding what the payer source criteria is. S18MD ED indicated he never discusses the patient ' s admission status of inpatient and/or observation because he does not know the difference between the two. S18MD ED denied informing Patient #4 and/or his family members of his admission status change from inpatient to outpatient/observation status because he did not know enough about it to explain the differences to the patients and/or family members. S18MD ED did not know who was to explain what the patient ' s admission status of inpatient and/or observation to the patients admitted from the emergency department to the unit. S18MD ED indicated there is a system failure regarding who and/or whom informs the patient ' s (#4 ' s) of their admission status of inpatient and/or observation status.

An interview was conducted on 03/08/12 from 9:30 a.m. through 9:50 a.m. with S27RN, Patient Access Coordinator (PAC). S27RN, PAC indicated the " InterQual Level of Care Criteria 2011 " is used to determine the admission status of observation and/or inpatient for patients. This index criterion is condition/diagnosis specific for " ACS " (Acute Coronary Syndrome) to determine whether or not the patient (#4) qualifies for observation and/or inpatient status. The information under the ACS index is compared with the physician ' s , (S18MD ED) " Acute Coronary Syndrome Orders " dated/timed 04/30/11 at 2:30 p.m. (1430) with the diagnosis of [DIAGNOSES REDACTED].m. (1249). S27RN verified the physician orders, ECG, lab work and blood pressure readings in the patient ' s (#4 ' s) medical record with the index criteria for Acute Coronary Syndrome during this interview as follows: the physician, S18MD ED wrote the Acute Coronary Syndrome Orders dated timed 04/30/11 at 2:30 p.m. (1430). The initial cardiac biomarkers negative (the Troponin-1 lab results on 04/30/11 and 05/01/11 were both negative). ECG was unchanged (normal sinus rhythm, pacemaker). Systolic BP baseline or >90 mmHG (132/82). Aspirin administered (physician ordered ASA 325 mg chewed NOW then Aspirin 325 mg 1 po daily and continue at discharge). Continuous cardiac monitoring (telemetry was ordered by the physician) ... " . S27RN PAC indicated the patient (#4) was assigned an observation status upon his admission into the hospital on [DATE] as per the " Acute Coronary Syndrome, Admission " criteria used for all Medicare patients. S27RN PAC further indicated the patient (#4) admission status of observation was followed as per the Medicare InterQual Level of Care Criteria 2011 for Acute Coronary Syndrome Admission guidelines during his hospital stay from 04/30/11 through 05/02/11. S27RN verified the " Acute Coronary Syndrome Admission Orders " by S18MD ED had inpatient scratched out on the form with outpatient circled. S27PAC nurse denied knowledge of whether or not she had informed the physician (S18MD ER) that the patient ' s admission status was changed from inpatient to observation/outpatient prior to the patient being admitted to the unit room " a " on 04/30/11. S27PAC nurse indicated she usually documents her Medicare diagnosis specific review for admission criteria on PAC notes. S27PAC further indicated she did not have her PAC notes indicating the date, time, and physician that she notified the physician (S18MD ED) of the patient ' s (#4 ' s) admission status after the Medicare diagnosis specific admission criteria was reviewed on 04/30/11 and/or 05/01/11.

In an interview on 03/08/12 from 11:20 a.m. to 11:26 a.m., S4Case Manager verified Patient #4 ' s admission status of observation was determined by the PAC nurse (S27RN) upon admission on 04/30/11 as per the Medicare specific diagnosis criteria for Acute Coronary Syndrome. S4Case Manager indicated the physician determines what the patient ' s admission status is. S4 continued the physician consults the PAC nurse to determine what the admission status of the patient (#4) is based on the patient ' s payer source. The PAC nurse notifies the ED physician usually prior to the patient (#4) being transferred from the emergency department to the unit of what the patient ' s admission status of inpatient and/or observation. The ED physician usually changes the admission status on the " Admission Orders " from inpatient to outpatient and/or observation status prior to transferring the patient to the unit. S4Case Manager verified S18MD ED ' s Admission Orders dated/timed 04/30/11 at 2:30 p.m. (1430) had inpatient scratched out on the form with outpatient circled. S4 indicated the PAC nurse informed the ED MD that the patient ' s admission status was observation/outpatient rather than inpatient status prior to the patient being admitted to room " a " .

During an interview on 03/08/12 at 9:10 a.m. and on 03/09/12 at 12:45 p.m., S1VP (vice president) of Clinical Services verified S18MD ED admitted Patient #4 for " Observation " as indicated on the " Acute Coronary Syndrome Orders on 04/30/11 at 2:30 p.m. (1430). S1VP of Clinical Services confirmed the patient ' s (#4 ' s) admission status of observation was followed as per the " InterQual Level of Care Criteria 2011 " for " Acute Coronary Syndrome Admission Criteria " used for all Medicare patients during the hospital stay from 04/30/11 through 05/02/11. S1VP of Clinical Services verified the " Acute Coronary Syndrome Admission Orders " by S18MD ED dated/timed 04/30/11 at 2:30 p.m. (1430) had inpatient scratched out on the form and outpatient was circled. S1 indicated it is the admitting department ' s responsibility to notify the patient of their admission status. S1VP of Clinical Services denied knowledge that it is the responsibility of the physician to inform the patient of their admission status.

The hospital failed to identify the Admission criteria policy was not being followed as evidenced by S1, S4, S27, and S18 were unable to articulate who is responsible in notifying/informing patients of their admission status.
VIOLATION: NURSING SERVICES Tag No: A0385
Based on observation, record review, and interview the hospital failed to meet the Condition of Participation for Nursing Services as evidenced by:

1) failing to ensure that the Registered Nurse supervised and evaluated the care of each patient as evidenced by having no documented evidence of Informed Consent for Blood/Blood Product transfusion and/or a physician's order to transfuse Blood/Blood products on the medical record for blood administration for 1 of 31 sampled patients (#11) and 4 of 5 focused sampled patients for Blood/Blood product administration. (#9, #R1, #R2, #R7) (see findings at A0395)

2) failing to ensure that Blood/Blood products were administered in accordance with hospital policy and procedure as evidenced by having no documented evidence of Informed Consent for Blood/Blood Product transfusion and/or a physician's order to transfuse Blood/Blood products on the medical record for blood administration for 1 of 31 sampled patients (#11) and 4 of 5 focused sampled patients for Blood/Blood product administration. (#9, #R1, #R2, #R7) (see findings at A0409)
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, record review, and interview the hospital failed to ensure that the Registered Nurse supervised and evaluated the care of each patient as evidenced by 1) having no documented evidence of Informed Consent for Blood/Blood Product transfusion and/or a physician's order to transfuse Blood/Blood products on the medical record for blood administration for 1 of 31 sampled patients (#11) and 4 of 5 focused sampled patients (#9, #R1, #R2, #R7) and 2) failing to investigate the complaint of a patient being hurt during a procedure by a non-hospital employee for 1 of 31 sampled patients (#8). Findings:

1) Patient #11

Review of the medical record of patient #11 revealed the patient was administered 1 unit of Packed Red Blood Cells (PRBC ' s) on 11/03/11 and 1 unit of Platelets on 11/09/11.

Review of a document titled "Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgement of Receipt of Medical Information" (not documented as completed until the Blood Product Transfusion on 11/09/12, 6 days after the transfusion of one unit of Packed Red Blood Cells (PRBC's) on 11/03/12) revealed the following: "Information About the Document - Read Carefully Before Signing. To the patient: You have been told that you should consider medical treatment/surgery. Louisiana law requires us to tell you (1) the nature of your condition, (2) the general nature of the medical treatment/surgery, (3) the risks of the proposed treatment/surgery, as defined by the Louisiana Medical Disclosure Panel or as determined by your doctor, (4) reasonable therapeutic alternatives and material risks associated with such alternatives, and (5) risks of no treatment. You have the right, as a patient, to be informed about your condition and the recommended surgical, medical or diagnostic procedure to be used so that you may make the decision whether or not to undergo the procedure after knowing the risks and hazards involved. In keeping with the Louisiana law of informed consent, you are being asked to sign a confirmation that we have discussed all these matters. We have already discussed with you the common problems and risks. We wish to inform you as completely as possible. Please read the form carefully. Ask about anything you do not understand, and well [sp?] will be pleased to explain. 1. Patient name: (last name of patient #11). 2. Treatment/Procedure: (a) ...Infusion of Blood and/or Blood Products. (b) Purpose: To correct a low blood count. 3. Patient's Condition: Patient's diagnosis, description of the nature of the condition or ailment for which the medical treatment, surgical procedure or other therapy described in item number 2 is indicated and recommended: (blank). Material Risks of treatment procedure: All medical or surgical treatment involves risks. Listed below are those risks associated with this procedure that we believe a reasonable person in you [sp?} (the patient's) position would likely consider significant when deciding whether to have or forego the proposed therapy. Please ask your physician if you would like additional information regarding the nature or consequences of these risks, their likelihood of occurrence, or other associated risks that you might consider significant but may not be listed below. (check box - not marked) See attachment for risks identified by the Louisiana Medical Disclosure Panel. (check box - not checked) See attachment for risks determined by your doctor. Additional risks, if any, particular to the patient because of a complicating medical condition are: (blank) ...6. Acknowledgement - Authorization and Consent. (a) No Guarantees: All information given to me and, in particular, all estimates made as to the likelihood of occurrence of risks of this or alternate procedures as to the prospects, are made in the best professional judgment of my physician. The possibility and nature of complications cannot always be accurately anticipated and therefore, there is and can be no guarantee, either express or implied, as to the success or other results of the medical or surgical procedure. (b) Additional Information: Nothing has been said to me, no information has been given to me, and I have not relied upon any information that is inconsistent with the information set forth in this document. (c) Particular concerns: I have had an opportunity to disclose and discuss with the physician providing such information, those risks or other potential consequences of the medical treatment or surgical procedures that are of particular concern to me. (d) Questions: I have had the opportunity to ask and I have asked questions I may have about the information in this document and any other questions I have about the proposed treatment of procedure and all such questions were answered in a satisfactory manner. (e) Authorized Physician: The physician (or physician group) authorized to administer or perform the medical treatment, surgical procedures or other therapy described in item 2 is: (Name of authorized physician or group)._______ (line is blank). (f) Physician Certification: I hereby certify that I have provided and explained the information set forth herein, including any attachment, and answered all questions of the patient, or the patient's representative, concerning the medical treatment or surgical procedure to the best of my knowledge and ability. __________ Signature of Physician or Certified Registered Nurse Anesthetist. Date/Time. (line is blank). CONSENT. Consent: I hereby authorize and direct the designated authorized physician/group, together with associates and assistants of his choice, to administer or perform the medical treatment or surgical procedure described in item 2 of this Consent Form, including any additional procedures or services as they may deem necessary or reasonable ...I (do) (do not) (neither choice is marked) consent to the use of blood and blood products, as deemed necessary. I have read and understand all information set forth in this document, including all attachment(s), and all blanks were filled in prior to my signing. This authorization for and consent to medical treatment or surgical procedure is and shall remain valid until revoked. I acknowledge that I have had the opportunity to ask questions about the contemplated medical procedure or surgical procedure described in item 2 of this consent form, including risks and alternatives, and acknowledge that my questions have been answered to my satisfaction." The document is witnessed by S6 RN dated 11/09/11 at 1510 (3:10 p.m.) and by (patient #11) dated/timed 11/09/11 at 1510 (3:10 p.m.).

Review of a document attached to the above consent form is a document titled: "Material Risks Identified by the Louisiana Medical Disclosure Panel" that revealed: "Patient Name: (patient #11). Procedure: Blood and Blood Components; Transfusion of. Material Risks: 1. Fever. 2. Transfusion Reaction which may include kidney failure or anemia. 3. Heart failure. 4. Hepatitis. 5. AIDS (acquired immune deficiency syndrome). 6. Other infections. Signature of Physician______ (line is blank). Witness: S6RN, dated/timed 11/09/10 (wrong year) at 1510 (3:10 p.m.). Patient or Person Authorized to Consent: 11/09/10 (wrong year) at 1510 (3:10 p.m.)."

Review of a document titled "Ambulatory Treatment Center (ATC) - Transfusion Orders" revealed the following: "Date: 11/3/11. Time: 8:00. 1. Admit to ATC as Outpatient. 2. Diagnosis: (ICD-9 codes 285.9, 157.0, 1552). 3. Diet as tolerated. 4. Vital signs per transfusion protocol. 5. Pre Lab Results: HgB (hemoglobin) 7.9, Hct (Hematocrit), 24.3. 6. Type and match for: (check box) Packed RBC ' s 1 unit ...7. Pre-medicate with: Tylenol 650 mg (milligrams) 1 po (by mouth), Decadron 20 mg 1 IV (intravenously), Pepcid 20 mg 1 IV, and Benadryl 25 mg 1 IV. " (all 4 of the listed medications are marked X (times) 1 prior to 1st transfusion." The "Physician Signature" line is signed by S12MD.

Review of a document titled "Blood Bank Issue Transfusion Record revealed the following: "...Patient: (patient #11) ...Ordering Doctor: (S12MD) ...Product: RBC LR Aph 2 (Red Blood Cells Leukocyte Reduced Apheresis) ...Transfusion Record. Before starting the transfusion, 2 nurses verify the following information: 1) Pt's name, MR# (medical record number), and BB (blood band) ID# on the Issue Transfusion Record matches the pt armbands. 2) Unit # (blood product) and unit ABO (The ABO blood group system is the most important blood type system (or blood group system) in human blood transfusion. Wikipedia.) and Rh type are the same on the Issue Transfuse Record and the Blood Bag. Transfusionist (signed by S5RN. Witnessed by S6RN. Transfusion Started: 11/03/11 at 1410 (2:10 p.m.)."

Further review of the documented Vital Signs for 11/03/11 during the Transfusion of Blood Products revealed the following vital signs were documented: "1/03/11 at 1410 (2:10 p.m.) (at the documented time of starting the Transfusion), 11/03/11 at 1535 (1 hour and 25 minutes after the documented start of the Transfusion), and 11/03/11 at 1600 (4:00 p.m.) (the time documented as "transfusion Completed." )

Review of the entire medical record for patient #11 revealed no Consent for Transfusion of Blood Products or Material Risks Identified by the Louisiana Medical Disclosure Panel prior to 11/09/11.

Review of a document titled "Ambulatory Treatment Center (ATC) - Transfusion Orders" revealed the following: " Date: 11/9/11. Time: 11:45. 1. Admit to ATC as Outpatient. 2. Diagnosis: (ICD-9 codes 287.4). 3. Diet as tolerated. 4. Vital signs per transfusion protocol. 5. Pre Lab Results: HgB (hemoglobin) 9.1, Hct (Hematocrit), 24.3. 6. Type and match for: (check box) Platelets 1 unit ...7. Pre-medicate with: Tylenol 650 mg (milligrams) 1 po (by mouth), Decadron 20 mg 1 IV (intravenously), Pepcid 20 mg 1 IV, and Benadryl 25 mg 1 IV. " (all 4 of the listed medications are marked X (times) 1 prior to 1st transfusion." The "Physician Signature" line is signed by S12MD.

Review of a document titled "Blood Bank Issue Transfusion Record revealed the following: "...Patient: (patient #11) ...Ordering Doctor: (S12MD) ...Product: Plt LR Aph (Platelet Leukocyte Reduced Apheresis)...Transfusion Record. Before starting the transfusion, 2 nurses verify the following information: 1) Pt's name, MR# (medical record number), and BB (blood band) ID# on the Issue Transfusion Record matches the pt armbands. 2) Unit # (blood product) and unit ABO (The ABO blood group system is the most important blood type system (or blood group system) in human blood transfusion. Wikipedia.) and Rh type are the same on the Issue Transfuse Record and the Blood Bag. Transfusionist (signed by S6RN). Witnessed by S17RN. Transfusion Started: 11/09/11 at 1330 (1:30 p.m.). "

Further review of the documented Vital Signs for 11/09/11 during the Transfusion of Blood Products revealed the following vital signs were documented: "11/09/11 at 1330 (1:30 p.m.) (at the documented time of starting the Transfusion), 11/09/11 at 1345 (15 minutes after the documented start of the Transfusion), 11/09/11 at 1415 (2:15 p.m.) (30 minutes after the documented start of the Transfusion) and 1440 (2:40 p.m.) (the time documented as "transfusion Completed.")

In an interview on 03/8/12 at 11:36 a.m. with S6RN she stated she witnessed the Blood Consent and Material Risk forms for patient #11 on 11/09/11 at 1510 (3:10 p.m.). S6RN confirmed she signed the Transfusion Record as the RN witness on 11/03/11 for the PRBC's administered to patient #11, 6 days prior to the Blood Consent and Material Risks form being signed by patient #11. S6RN further confirmed that she signed the Transfusion Record as the transfusionist on 11/09/11 for the Platelets administered to patient #11 on 11/09/11, the day the consent was signed by patient #11 with no physician signature. S6RN confirmed there was no physician signature on the consent. S6RN further stated that she is aware of the hospital policy NR-2-6-001 and NR-2-6-020.

In an interview on 03/07/12 at 2:00 p.m. with S1VP Clinical Services she stated that the Blood Transfusion Consent for patient #11 was incomplete and that neither the PRBC's (on 11/03/12) or Platelets transfused (on 11/09/12) to patient #11 should have been administered. S1VP Clinical Services also presented a revised version of the "Ambulatory Treatment Center: Transfusion Orders", revised 02/2012 that now included the following: "8. Transfuse _______units PRBC's on ________ (date). 9. Transfuse ________units Platelets on ________ (date)."

On 03/08/12 at 12:30 p.m. the sample was expanded to include the 5 (five) most recent medical records for patients receiving Blood or Blood Products on the ATC. The following records were reviewed. (#9, #12, #R1, #R2, #R3) In addition an observation was made on the ATC on 03/08/12 at 1:05 p.m. where one (#R7) patient was receiving Blood.

Patient # 9

Review of the Blood and/or Blood Product Consent revealed: "...2.a. Description, nature, benefits of the treatment/procedure: Blank ...8.f. Physician Certification: I hereby certify that I have provided and explained the information set forth herein, including any attachment, and answered all questions of the patient, or the patient's representative, concerning the medical treatment or surgical procedure, to the best of my knowledge and ability. Signature of Physician. (Blank). Date/Time: (Blank) ...CONSENT ...I have read and understand all information set forth in this document, including any attachment(s), and all blanks were filled in prior to my signing ..." The document is witnessed by S17RN on 03/06/12 at 8:30 a.m. and signed by patient #9 on 03/06/12 at 8:30 a.m.

Review of the "Material Risks Identified by The Louisiana Medical Disclosure Panel" revealed it was witnessed by S17RN on 03/06/12 at 8:30 a.m. and signed by patient #9 on 03/06/12 at 8:30 a.m. Further review revealed no physician's signature on the document.

Patient #R1

Review of the Blood and/or Blood Product Consent revealed: "...2.a. Description, nature, benefits of the treatment/procedure: Blank ...8.f. Physician Certification: I hereby certify that I have provided and explained the information set forth herein, including any attachment, and answered all questions of the patient, or the patient ' s representative, concerning the medical treatment or surgical procedure, to the best of my knowledge and ability. Signature of Physician. (Blank). Date/Time: (Blank)...CONSENT...I have read and understand all information set forth in this document, including any attachment(s), and all blanks were filled in prior to my signing ..." The document is witnessed by S7RN on 03/06/12 at 8:10 a.m. and signed by patient #R1 on 03/06/12 at 8:10 a.m.

Review of the "Material Risks Identified by The Louisiana Medical Disclosure Panel" revealed it was witnessed by S6RN on 03/06/12 at 8:30 a.m. and signed by patient #R1 on 03/06/12 at 8:30 a.m. Further review revealed no physician's signature on the document.
In an interview on 03/08/12 at 1:20 p.m. with S7RN she confirmed that the Blood Product Consent and the Material Risks From were not signed by the physician.

Patient #R2

Review of the Blood and/or Blood Product Consent revealed: "...2.a. Description, nature, benefits of the treatment/procedure: Blank...8.f. Physician Certification: I hereby certify that I have provided and explained the information set forth herein, including any attachment, and answered all questions of the patient, or the patient's representative, concerning the medical treatment or surgical procedure, to the best of my knowledge and ability. Signature of Physician. (Blank). Date/Time: (Blank)...CONSENT...I have read and understand all information set forth in this document, including any attachment(s), and all blanks were filled in prior to my signing..." The document is witnessed by S7RN on 03/07/12 at 10:25 a.m. and signed by patient #R2 on 03/07/12 at 10:25 a.m.

Review of the "Material Risks Identified by The Louisiana Medical Disclosure Panel" revealed it was witnessed by S7RN on 03/06/12 at 8:30 a.m. and signed by patient #R2 on 03/06/12 at 8:30 a.m. Further review revealed no physician's signature on the document.

In an interview on 03/08/12 at 1:20 p.m. with S6RN she confirmed that the Blood Product Consent and the Material Risks From were not signed by the physician.

Patient #R7 (observation on the ATC on 03/08/12 at 1:05 p.m.)

In an observation made on the ATC on 03/08/12 at 1:05 p.m. it was noted that one patient was receiving Blood. S6RN and S7RN were on duty on the unit. S1VP Clinical Services accompanied the surveyor ' s to the unit.

Patient # R7 was on the unit and was receiving PRBC's via her Medi-Port.

Review of the Blood and/or Blood Product Consent revealed: "...2.a. Description, nature, benefits of the treatment/procedure: Blank...8.f. Physician Certification: I hereby certify that I have provided and explained the information set forth herein, including any attachment, and answered all questions of the patient, or the patient's representative, concerning the medical treatment or surgical procedure, to the best of my knowledge and ability. Signature of Physician. (Blank). Date/Time: (Blank)...CONSENT: I have read and understand all information set forth in this document, including any attachment(s), and all blanks were filled in prior to my signing..." The document is witnessed by S17RN on 03/02/12 at 8:13 a.m. and signed by patient #R7 on 03/02/12 at 8:13 a.m.

Review of the "Material Risks Identified by The Louisiana Medical Disclosure Panel" revealed it was witnessed by S17RN on 03/02/12 at 8:13 a.m. and signed by patient #R7 on 03/02/12 at 8:13 a.m. Further review revealed no physician's signature on the document.
In an interview on 03/08/12 at 1:20 p.m. with S6RN and S7RN both confirmed that the Blood Product Consent and the Material Risks From were not signed by the physician.

In an interview at the time of observation (03/08/12 at 1:05 p.m.) S6RN confirmed that the order set being used for patient #R7 did have an order to Type and Match for 2 units of PRBC's, but contained no order to transfuse.

In an interview at the time of observation (03/08/12 at 1:05 p.m.) S7RN confirmed that the order set being used for patient #R7 did have an order to Type and Match for 2 units of PRBC's, but contained no order to transfuse. S7RN stated she "assumed there was." S7RN further stated that it was "routine here to give blood with no physicians signature on the consent."

In an interview on 03/08/12 at 1:03 p.m. S1VP Clinical Services presented a document with the following documentation: "ATC meeting with following physicians: (S10MD) - Feb. 3, 2012 at 1pm. (S12MD) - Feb. 10, 2012 at 0900 (9:00 a.m.). Issues addressed: New Transfusion Order Set. Blood Consent Requirements..." S1VP Clinical Services stated that this document was prepared by S11RN, Director of ATC, on 03/07/12. S1VP Clinical stated S11RN was not available for interview.

In an interview on 03/09/12 with S12MD at 8:35 a.m. he stated he discusses the lab work (Hemoglobin and Hematocrit) and the need for Blood Transfusion with his patients in his office. S12MD further stated he explains the risks and benefits with the patients in his office. S12MD stated he has not been sending a signed "Consent for Blood Products" to the hospital with the patient. S12MD confirmed the "Transfusion Order" sheet used by the hospital prior to 02/12 and the "Transfusion Order" sheet sent by his office (for the transfusion in progress) on patient #R7 did not contain a specific order to transfuse Blood to the patient. S12MD stated he would expect nurse's to call for clarification if orders were not clear. S12MD stated that prior to the morning of his interview with surveyor's (03/08/12) he had never seen the "new" order set presented to the surveyor's.

In an interview on 03/09/12 at 9:32 a.m. with S10 MD he stated he was not aware of issues with consent forms not being signed by the physician or the hospital policy indicating a physician signature was needed. S10MD stated he was not "the institute administering the blood and I am not responsible for consent." He further stated that consent was done by the nurse at the ATC. S10MD further stated that the re-education the hospital documented as taking place on Feb. 3rd, 2012 "never occurred."

In a telephone interview on 03/09/12 at 9:41 a.m. with S13Chief Medical Officer (CMO) he stated it was up to the attending physician to consent the patient. He further stated that "if the physician is ordering blood the physician should perform the Informed Consent."

Review of a hospital policy titled "Blood Transfusion Procedure", policy number NR-2-6-001, issue date: 04/88, last revised 05/11, presented as current hospital policy, read in part: "Standard of Care. The patient can expect to receive compatible blood for transfusion and be monitored for possible reactions allowing for privacy in a safe and competent manner. Standard of Practice. The RN (Registered Nurse) will administer blood products in a safe and competent manner and allow for patient's privacy. Designated Personnel: RN ...Procedure: I. Verify physician's order ...IV. B. The Consent and Material Risk Form is signed by the patient and doctor and placed in the patient's chart. The administration of the blood product is not to occur until the consent is signed. In the event the physician is unavailable, such as night time, the Consent and Material Risk form will be dated, timed, and signed by the physician/LIP (licensed independent practitioner within 24 hours ...VIII. Place order to TRANSFUSE in the computer system when you are ready to hang blood ...1. Verify that a Consent Form has been signed by the patient and doctor and is on the chart. 2. Verify that a MATERIAL RISKS OF TRANSFUSION has been signed by the patient and doctor and is on the chart ...X. Obtain vital signs. Record on the Blood Transfusion Flow Sheet: A. The flow sheet MUST STAY ATTACHED TO THE UNIT until completion of transfusion ...1. This will serve as baseline in case the patient has adverse reaction. 2. Vital signs should be taken at the following intervals. a. Prior to transfusion-baseline. b. 15 minutes after start of transfusion. c. Every 30 minutes for duration of transfusion. d. At completion of transfusion. e. One hour post transfusion ..."

Review of a hospital policy titled "Platelet Transfusion Procedure/Care of Patient", policy number NR-2-6-020, issued 04/88, revised/approved date: 05/11, presented as current hospital policy, reads in part: "Standard of Care: The patient/caregiver can expect the patient to receive appropriate platelet infusion or bolus and be monitored privately for possible reactions. Standard of Practice: The RN will administer platelets in a safe, private and competent manner ...Procedure. I. Verify physician's order. I ...b. Verify education and consent forms are on chart. The administration of blood product is not to occur until the consent is signed. In the event the physician is unavailable, such as night time, the Consent and Material Risk form will be dated, timed, and signed by the physician/LIP within 24 [hours]. VII. Obtain vital signs. Record on the Blood Transfusion Flow Sheet: A. The flow sheet MUST STAY ATTACHED TO THE UNIT until completion of transfusion ...1. This will serve as baseline in case the patient has adverse reaction. 2. Vital signs should be taken at the following intervals. a. Prior to transfusion-baseline. b. 15 minutes after start of transfusion. c. Every 30 minutes for duration of transfusion. d. At completion of transfusion. e. One hour post transfusion ..."

Review of a hospital policy titled "Informed Consent", policy number RI-A-030, issued January 15, 1997, last revised 11/11, presented as current hospital policy, revealed: "General Statement. It is our belief that persons have the right to be involved in all aspects of their care. The purpose of this policy is twofold: 1) to insure that a patient's right to be informed and to participate in decision-making is protected and defined, and 2) to insure compliance with applicable federal and state statutes and other regulating bodies. Policy: A. Consent is the voluntary agreement of a person with decision making capacity to make an intelligent choice to do something proposed by another. Informed consent to medical treatment means a consent in writing to any medical or surgical procedures or course of procedures which: 1. Sets forth in general terms the nature of the procedure or procedures, together with known risks ...2. Acknowledges that such disclosure of information has been made ...3. is signed by the patient for whom the procedure is to be performed ...Informed consent is not merely obtaining a signed document. It is an ongoing process that considers the patient's needs and preferences, compliance with institutional policies, the law...B. As a fundamental aspect of the physician/patient relationship and before a patient gives his consent, the physician who will actually perform the medical or surgical procedure must clearly explain to the patient...the following: Source: La. Rev. Stat. Ann. 40:1299.40(A)(1). 1. Nature of pertinent ailment or condition and general nature of proposed treatment or procedure. 2. Potential benefits and known risks...5. Possible results of non-treatment. 6. Risks and benefits of any reasonable therapeutic alternatives ...C. A consent form will be completed and executed by the patient or the patient's health care decision maker prior to the performance of any procedures listed in the Louisiana Medical Disclosure Panel's procedures that require Disclosure...E. Surgical and/or Special Consent Forms. These completed forms should be used for the following:..6. When the treating physician determines that the patient will require transfusion(s) of blood and/or blood products...K. Documenting the Consent Given:..4. The names, both of the person giving consent and of those who heard it, must be documented in the medical record ...Informed Consent:..3. The attending physician is responsible for verifying the validity of the consent form. This responsibility is not delegated or alleviated by nursing staff documenting the physician's consent conference with the patient by obtaining the patient's signature on the hospital consent form...."

Review of LA R.S. ?1299.40 revealed the following:

PART XXII. UNIFORM CONSENT LAW

?1299.40. Consent to medical treatment; exception; Louisiana Medical Disclosure Panel; availability of lists to establish necessity and degree. A.(1) Notwithstanding any other law to the contrary, written consent to medical treatment means a handwritten consent to any medical or surgical procedure or course of procedures which: sets forth in general terms the nature and purpose of the procedure or procedures, together with the known risks, if any, of death, brain damage, quadriplegia, [DIAGNOSES REDACTED], the loss or loss of function of any organ or limb, of disfiguring scars associated with such procedure or procedures; acknowledges that such disclosure of information has been made and that all questions asked about the procedure or procedures have been answered in a satisfactory manner; and is signed by the patient for whom the procedure is to be performed, or if the patient for any reason lacks legal capacity to consent by a person who has legal authority to consent on behalf of such patient in such circumstances. Such consent shall be presumed to be valid and effective, in the absence of proof that execution of the consent was induced by misrepresentation of material facts ...B. Except as provided in Subsection A of this Section, no evidence shall be admissible to modify or limit the authorization for performance of the procedure or procedures set forth in such written consent. C. Where consent to medical treatment from a patient, or from a person authorized by law to consent to medical treatment for such patient, is secured other than in accordance with Subsection A above, the explanation to the patient or to the person consenting for such patient shall include the matters set forth in Paragraph (1) of Subsection A above, and an opportunity shall be afforded for asking questions concerning the procedures to be performed which shall be answered in a satisfactory manner. Such consent shall be valid and effective and is subject to proof according to the rules of evidence in ordinary cases (b) Consent to medical treatment may be evidenced according to the provisions of Subsections A and C of this Section or, as an alternative, a physician or other health care provider may choose to avail himself of the lists established by the Louisiana Medical Disclosure Panel pursuant to the provisions of this Subsection as another method by which to evidence a patient's consent to medical treatment ...(3)(a) The Louisiana Medical Disclosure Panel is created within the Department of Health and Hospitals to determine which risks and hazards related to medical care and surgical procedures must be disclosed by a physician or other health care provider to a patient or person authorized to consent for a patient and to establish the general form and substance of such disclosure ...(b) The panel shall prepare separate lists of those medical treatments and surgical procedures that do and do not require disclosure and for those treatments and procedures that do require disclosure shall establish the degree of disclosure required and the form in which the disclosure will be made ...(c) Lists prepared under Subparagraph 4(b) of this Subsection together with written explanations of the degree and form of disclosure shall be promulgated according to the Administrative Procedure Act. The form of the disclosure and manner in which such disclosure will be made shall be subject to legislative oversight by the House and Senate Health and Welfare Committees. The initial lists of the panel shall be published on or before January 1, 1991, or at such time as soon after that date as the panel determines to be feasible, but, in no event, shall the initial lists be published later than March 1, 1991. The lists compiled and published and rules promulgated relative to the form and manner of disclosure according to the provisions of this Subsection and evidence of such disclosures or failure to disclose by a physician or other health care provider as provided in Paragraphs (5) and (6) of this Subsection, shall be admissible in a health care liability suit or medical malpractice claim involving medical care rendered or a surgical procedure performed on or after March 1, 1991 ...(5) Before a patient or a person authorized to consent for a patient gives consent to any medical or surgical procedure that appears on the panel's list requiring disclosure, the physician or other health care provider shall disclose to the patient, or person authorized to consent for the patient, the risks and hazards involved in that kind of care or procedure. A physician or other health care provider may choose to utilize the lists prepared by the panel and shall be considered to have complied with the requirements of this Subsection if disclosure is made as provided in Paragraph (6) of this Subsection ...(6) Consent to medical care that appears on the panel's list requiring disclosure shall be considered effective under this Subsection, if it is given in writing, signed by the patient or a person authorized to give the consent and by a competent witness, and if the written consent specifically states, in such terms and language that a layman would be expected to understand, the risks and hazards that are involved in the medical care or surgical procedure in the form and to the degree required by the panel under Paragraph (4) of this Subsection ...(7)(a) In a suit against a physician or other health care provider involving a health care liability or medical malpractice claim which is based on the negligent failure of the physician or other health care provider to disclose or adequately to disclose the risks and hazards involved in the medical care or surgical procedure rendered by the physician or other health care provider: (i) Both the disclosure made as provided in Paragraph (5) of this Subsection and the failure to disclose based on inclusion of any medical care or surgical procedure on the panel's list for which disclosure is not required shall be admissible in evidence and shall create a rebuttable presumption that the requirements of Paragraphs (5) and (6) of thi
VIOLATION: BLOOD TRANSFUSIONS AND IV MEDICATIONS Tag No: A0409
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, record review, and interview the hospital failed to ensure that Blood/Blood products were administered in accordance with hospital policy and procedure as evidenced by having no documented evidence of Informed Consent for Blood/Blood Product transfusion and/or a physician's order to transfuse Blood/Blood products on the medical record for blood administration for 1 of 31 sampled patients (#11)
and 4 of 5 focused sampled patients for Blood/Blood product administration. (#9, #R1, #R2, #R7) Findings:

Patient #11

Review of the medical record of patient #11 revealed the patient was administered 1 unit of Packed Red Blood Cells (PRBC ' s) on 11/03/11 and 1 unit of Platelets on 11/09/11.

Review of a document titled "Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgement of Receipt of Medical Information" (not documented as completed until the Blood Product Transfusion on 11/09/12, 6 days after the transfusion of one unit of Packed Red Blood Cells (PRBC ' s) on 11/03/12) revealed the following: "Information About the Document - Read Carefully Before Signing. To the patient: You have been told that you should consider medical treatment/surgery. Louisiana law requires us to tell you (1) the nature of your condition, (2) the general nature of the medical treatment/surgery, (3) the risks of the proposed treatment/surgery, as defined by the Louisiana Medical Disclosure Panel or as determined by your doctor, (4) reasonable therapeutic alternatives and material risks associated with such alternatives, and (5) risks of no treatment. You have the right, as a patient, to be informed about your condition and the recommended surgical, medical or diagnostic procedure to be used so that you may make the decision whether or not to undergo the procedure after knowing the risks and hazards involved. In keeping with the Louisiana law of informed consent, you are being asked to sign a confirmation that we have discussed all these matters. We have already discussed with you the common problems and risks. We wish to inform you as completely as possible. Please read the form carefully. Ask about anything you do not understand, and well [sp?] will be pleased to explain. 1. Patient name: (last name of patient #11). 2. Treatment/Procedure: (a) ...Infusion of Blood and/or Blood Products. (b) Purpose: To correct a low blood count. 3. Patient ' s Condition: Patient's diagnosis, description of the nature of the condition or ailment for which the medical treatment, surgical procedure or other therapy described in item number 2 is indicated and recommended: (blank). Material Risks of treatment procedure: All medical or surgical treatment involves risks. Listed below are those risks associated with this procedure that we believe a reasonable person in you [sp?} (the patient's) position would likely consider significant when deciding whether to have or forego the proposed therapy. Please ask your physician if you would like additional information regarding the nature or consequences of these risks, their likelihood of occurrence, or other associated risks that you might consider significant but may not be listed below. (check box - not marked) See attachment for risks identified by the Louisiana Medical Disclosure Panel. (check box - not checked) See attachment for risks determined by your doctor. Additional risks, if any, particular to the patient because of a complicating medical condition are: (blank) ...6. Acknowledgement - Authorization and Consent. (a) No Guarantees: All information given to me and, in particular, all estimates made as to the likelihood of occurrence of risks of this or alternate procedures as to the prospects, are made in the best professional judgment of my physician. The possibility and nature of complications cannot always be accurately anticipated and therefore, there is and can be no guarantee, either express or implied, as to the success or other results of the medical or surgical procedure. (b) Additional Information: Nothing has been said to me, no information has been given to me, and I have not relied upon any information that is inconsistent with the information set forth in this document. (c) Particular concerns: I have had an opportunity to disclose and discuss with the physician providing such information, those risks or other potential consequences of the medical treatment or surgical procedures that are of particular concern to me. (d) Questions: I have had the opportunity to ask and I have asked questions I may have about the information in this document and any other questions I have about the proposed treatment of procedure and all such questions were answered in a satisfactory manner. (e) Authorized Physician: The physician (or physician group) authorized to administer or perform the medical treatment, surgical procedures or other therapy described in item 2 is: (Name of authorized physician or group)._______ (line is blank). (f) Physician Certification: I hereby certify that I have provided and explained the information set forth herein, including any attachment, and answered all questions of the patient, or the patient's representative, concerning the medical treatment or surgical procedure to the best of my knowledge and ability. __________ Signature of Physician or Certified Registered Nurse Anesthetist. Date/Time. (line is blank). CONSENT. Consent: I hereby authorize and direct the designated authorized physician/group, together with associates and assistants of his choice, to administer or perform the medical treatment or surgical procedure described in item 2 of this Consent Form, including any additional procedures or services as they may deem necessary or reasonable ...I (do) (do not) (neither choice is marked) consent to the use of blood and blood products, as deemed necessary. I have read and understand all information set forth in this document, including all attachment(s), and all blanks were filled in prior to my signing. This authorization for and consent to medical treatment or surgical procedure is and shall remain valid until revoked. I acknowledge that I have had the opportunity to ask questions about the contemplated medical procedure or surgical procedure described in item 2 of this consent form, including risks and alternatives, and acknowledge that my questions have been answered to my satisfaction. " The document is witnessed by S6 RN dated 11/09/11 at 1510 (3:10 p.m.) and by (patient #11) dated/timed 11/09/11 at 1510 (3:10 p.m.).

Review of a document attached to the above consent form is a document titled: "Material Risks Identified by the Louisiana Medical Disclosure Panel" that revealed: "Patient Name: (patient #11). Procedure: Blood and Blood Components; Transfusion of. Material Risks: 1. Fever. 2. Transfusion Reaction which may include kidney failure or anemia. 3. Heart failure. 4. Hepatitis. 5. AIDS (acquired immune deficiency syndrome). 6. Other infections. Signature of Physician______ (line is blank). Witness: S6RN, dated/timed 11/09/10 (wrong year) at 1510 (3:10 p.m.). Patient or Person Authorized to Consent: 11/09/10 (wrong year) at 1510 (3:10 p.m.)."

Review of a document titled "Ambulatory Treatment Center (ATC) - Transfusion Orders" revealed the following: "Date: 11/3/11. Time: 8:00. 1. Admit to ATC as Outpatient. 2. Diagnosis: (ICD-9 codes 285.9, 157.0, 1552). 3. Diet as tolerated. 4. Vital signs per transfusion protocol. 5. Pre Lab Results: HgB (hemoglobin) 7.9, Hct (Hematocrit), 24.3. 6. Type and match for: (check box) Packed RBC ' s 1 unit ...7. Pre-medicate with: Tylenol 650 mg (milligrams) 1 po (by mouth), Decadron 20 mg 1 IV (intravenously), Pepcid 20 mg 1 IV, and Benadryl 25 mg 1 IV. " (all 4 of the listed medications are marked X (times) 1 prior to 1st transfusion." The "Physician Signature" line is signed by S12MD.

Review of a document titled "Blood Bank Issue Transfusion Record revealed the following: "...Patient: (patient #11)...Ordering Doctor: (S12MD)...Product: RBC LR Aph 2 (Red Blood Cells Leukocyte Reduced Apheresis)...Transfusion Record. Before starting the transfusion, 2 nurses verify the following information: 1) Pt's name, MR# (medical record number), and BB (blood band) ID# on the Issue Transfusion Record matches the pt armbands. 2) Unit # (blood product) and unit ABO (The ABO blood group system is the most important blood type system (or blood group system) in human blood transfusion. Wikipedia.) and Rh type are the same on the Issue Transfuse Record and the Blood Bag. Transfusionist (signed by S5RN. Witnessed by S6RN. Transfusion Started: 11/03/11 at 1410 (2:10 p.m.).Review of the Vital Signs for 11/03/11 during the Transfusion of Blood Products revealed the following vital signs were documented: "11/03/11 at 1410 (2:10 p.m.) (at the documented time of starting the Transfusion), 11/03/11 at 1535 (1 hour and 25 minutes after the documented start of the Transfusion), and 11/03/11 at 1600 (4:00 p.m.) (the time documented as "transfusion Completed.")

Review of the entire medical record for patient #11 revealed no Consent for Transfusion of Blood Products or Material Risks Identified by the Louisiana Medical Disclosure Panel prior to 11/09/11.

Review of a document titled "Ambulatory Treatment Center (ATC) - Transfusion Orders" revealed the following: "Date: 11/9/11. Time: 11:45. 1. Admit to ATC as Outpatient. 2. Diagnosis: (ICD-9 codes 287.4). 3. Diet as tolerated. 4. Vital signs per transfusion protocol. 5. Pre Lab Results: HgB (hemoglobin) 9.1, Hct (Hematocrit), 24.3. 6. Type and match for: (check box) Platelets 1 unit ...7. Pre-medicate with: Tylenol 650 mg (milligrams) 1 po (by mouth), Decadron 20 mg 1 IV (intravenously), Pepcid 20 mg 1 IV, and Benadryl 25 mg 1 IV." (all 4 of the listed medications are marked X (times) 1 prior to 1st transfusion." The "Physician Signature" line is signed by S12MD.

Review of a document titled "Blood Bank Issue Transfusion Record revealed the following: "...Patient: (patient #11)...Ordering Doctor: (S12MD)...Product: Plt LR Aph (Platelet Leukocyte Reduced Apheresis)...Transfusion Record. Before starting the transfusion, 2 nurses verify the following information: 1) Pt's name, MR# (medical record number), and BB (blood band) ID# on the Issue Transfusion Record matches the pt armbands. 2) Unit # (blood product) and unit ABO (The ABO blood group system is the most important blood type system (or blood group system) in human blood transfusion. Wikipedia.) and Rh type are the same on the Issue Transfuse Record and the Blood Bag. Transfusionist (signed by S6RN). Witnessed by S17RN. Transfusion Started: 11/09/11 at 1330 (1:30 p.m.).Review of the documented Vital Signs for 11/09/11 during the Transfusion of Blood Products revealed the following vital signs were documented: "11/09/11 at 1330 (1:30 p.m.) (at the documented time of starting the Transfusion), 11/09/11 at 1345 (15 minutes after the documented start of the Transfusion), 11/09/11 at 1415 (2:15 p.m.) (30 minutes after the documented start of the Transfusion) and 1440 (2:40 p.m.) (the time documented as "transfusion Completed.")

In an interview on 03/8/12 at 11:36 a.m. with S6RN she stated she witnessed the Blood Consent and Material Risk forms for patient #11 on 11/09/11 at 1510 (3:10 p.m.). S6RN confirmed she signed the Transfusion Record as the RN witness on 11/03/11 for the PRBC's administered to patient #11, 6 days prior to the Blood Consent and Material Risks form being signed by patient #11. S6RN further confirmed that she signed the Transfusion Record as the transfusionist on 11/09/11 for the Platelets administered to patient #11 on 11/09/11, the day the consent was signed by patient #11 with no physician signature. S6RN confirmed there was no physician signature on the consent. S6RN further stated that she is aware of the hospital policy NR-2-6-001 and NR-2-6-020.

In an interview on 03/07/12 at 2:00 p.m. with S1VP Clinical Services she stated that the Blood Transfusion Consent for patient #11 was incomplete and that neither the PRBC's (on 11/03/12) or Platelets transfused (on 11/09/12) to patient #11 should have been administered. S1VP Clinical Services also presented a revised version of the "Ambulatory Treatment Center: Transfusion Orders", revised 02/2012 that now included the following: "8. Transfuse _______units PRBC's on ________ (date). 9. Transfuse ________units Platelets on ________ (date)."

On 03/08/12 at 12:30 p.m. the sample was expanded to include the 5 (five) most recent medical records for patients receiving Blood or Blood Products on the ATC. The following records were reviewed. (#9, #12, #R1, #R2, #R3) In addition an observation was made on the ATC on 03/08/12 at 1:05 p.m. where one (#R7) patient was receiving Blood.

Patient # 9

Review of the Blood and/or Blood Product Consent revealed: "...2.a. Description, nature, benefits of the treatment/procedure: Blank ...8.f. Physician Certification: I hereby certify that I have provided and explained the information set forth herein, including any attachment, and answered all questions of the patient, or the patient ' s representative, concerning the medical treatment or surgical procedure, to the best of my knowledge and ability. Signature of Physician. (Blank). Date/Time: (Blank)...CONSENT...I have read and understand all information set forth in this document, including any attachment(s), and all blanks were filled in prior to my signing..." The document is witnessed by S17RN on 03/06/12 at 8:30 a.m. and signed by patient #9 on 03/06/12 at 8:30 a.m.

Review of the "Material Risks Identified by The Louisiana Medical Disclosure Panel" revealed it was witnessed by S17RN on 03/06/12 at 8:30 a.m. and signed by patient #9 on 03/06/12 at 8:30 a.m. Further review revealed no physician's signature on the document.

Patient #R1

Review of the Blood and/or Blood Product Consent revealed: "...2.a. Description, nature, benefits of the treatment/procedure: Blank...8.f. Physician Certification: I hereby certify that I have provided and explained the information set forth herein, including any attachment, and answered all questions of the patient, or the patient's representative, concerning the medical treatment or surgical procedure, to the best of my knowledge and ability. Signature of Physician. (Blank). Date/Time: (Blank)...CONSENT...I have read and understand all information set forth in this document, including any attachment(s), and all blanks were filled in prior to my signing..." The document is witnessed by S7RN on 03/06/12 at 8:10 a.m. and signed by patient #R1 on 03/06/12 at 8:10 a.m.

Review of the "Material Risks Identified by The Louisiana Medical Disclosure Panel" revealed it was witnessed by S6RN on 03/06/12 at 8:30 a.m. and signed by patient #R1 on 03/06/12 at 8:30 a.m. Further review revealed no physician's signature on the document.
In an interview on 03/08/12 at 1:20 p.m. with S7RN she confirmed that the Blood Product Consent and the Material Risks From were not signed by the physician.

Patient #R2

Review of the Blood and/or Blood Product Consent revealed: "...2.a. Description, nature, benefits of the treatment/procedure: Blank...8.f. Physician Certification: I hereby certify that I have provided and explained the information set forth herein, including any attachment, and answered all questions of the patient, or the patient's representative, concerning the medical treatment or surgical procedure, to the best of my knowledge and ability. Signature of Physician. (Blank). Date/Time: (Blank)...CONSENT...I have read and understand all information set forth in this document, including any attachment(s), and all blanks were filled in prior to my signing..." The document is witnessed by S7RN on 03/07/12 at 10:25 a.m. and signed by patient #R2 on 03/07/12 at 10:25 a.m.

Review of the "Material Risks Identified by The Louisiana Medical Disclosure Panel" revealed it was witnessed by S7RN on 03/06/12 at 8:30 a.m. and signed by patient #R2 on 03/06/12 at 8:30 a.m. Further review revealed no physician's signature on the document.

In an interview on 03/08/12 at 1:20 p.m. with S6RN she confirmed that the Blood Product Consent and the Material Risks From were not signed by the physician.

Patient #R7 (observation on the ATC on 03/08/12 at 1:05 p.m.)

In an observation made on the ATC on 03/08/12 at 1:05 p.m. it was noted that one patient was receiving Blood. S6RN and S7RN were on duty on the unit. S1VP Clinical Services accompanied the surveyor's to the unit.

Patient # R7 was on the unit and was receiving PRBC's via her Medi-Port.

Review of the Blood and/or Blood Product Consent revealed: "...2.a. Description, nature, benefits of the treatment/procedure: Blank...8.f. Physician Certification: I hereby certify that I have provided and explained the information set forth herein, including any attachment, and answered all questions of the patient, or the patient's representative, concerning the medical treatment or surgical procedure, to the best of my knowledge and ability. Signature of Physician. (Blank). Date/Time: (Blank) ...CONSENT ...I have read and understand all information set forth in this document, including any attachment(s), and all blanks were filled in prior to my signing..." The document is witnessed by S17RN on 03/02/12 at 8:13 a.m. and signed by patient #R7 on 03/02/12 at 8:13 a.m.

Review of the "Material Risks Identified by The Louisiana Medical Disclosure Panel" revealed it was witnessed by S17RN on 03/02/12 at 8:13 a.m. and signed by patient #R7 on 03/02/12 at 8:13 a.m. Further review revealed no physician's signature on the document.
In an interview on 03/08/12 at 1:20 p.m. with S6RN and S7RN both confirmed that the Blood Product Consent and the Material Risks From were not signed by the physician.

In an interview at the time of observation (03/08/12 at 1:05 p.m.) S6RN confirmed that the order set being used for patient #R7 did have an order to Type and Match for 2 units of PRBC's, but contained no order to transfuse.

In an interview at the time of observation (03/08/12 at 1:05 p.m.) S7RN confirmed that the order set being used for patient #R7 did have an order to Type and Match for 2 units of PRBC's, but contained no order to transfuse. S7RN stated she "assumed there was." S7RN further stated that it was "routine here to give blood with no physicians signature on the consent."

In an interview on 03/08/12 at 1:03 p.m. S1VP Clinical Services presented a document with the following documentation: "ATC meeting with following physicians: (S10MD) - Feb. 3, 2012 at 1pm. (S12MD) - Feb. 10, 2012 at 0900 (9:00 a.m.). Issues addressed: New Transfusion Order Set. Blood Consent Requirements..." S1VP Clinical Services stated that this document was prepared by S11RN, Director of ATC, on 03/07/12. S1VP Clinical stated S11RN was not available for interview.

In an interview on 03/09/12 with S12MD at 8:35 a.m. he stated he discusses the lab work (Hemoglobin and Hematocrit) and the need for Blood Transfusion with his patients in his office. S12MD further stated he explains the risks and benefits with the patients in his office. S12MD stated he has not been sending a signed "Consent for Blood Products" to the hospital with the patient. S12MD confirmed the "Transfusion Order" sheet used by the hospital prior to 02/12 and the "Transfusion Order" sheet sent by his office (for the transfusion in progress) on patient #R7 did not contain a specific order to transfuse Blood to the patient. S12MD stated he would expect nurse's to call for clarification if orders were not clear. S12MD stated that prior to the morning of his interview with surveyor's (03/08/12) he had never seen the "new" order set presented to the surveyor's.

In an interview on 03/09/12 at 9:32 a.m. with S10 MD he stated he was not aware of issues with consent forms not being signed by the physician or the hospital policy indicating a physician signature was needed. S10MD stated he was not "the institute administering the blood and I am not responsible for consent." He further stated that consent was done by the nurse at the ATC. S10MD further stated that the re-education the hospital documented as taking place on Feb. 3rd, 2012 "never occurred."

In a telephone interview on 03/09/12 at 9:41 a.m. with S13Chief Medical Officer (CMO) he stated it was up to the attending physician to consent the patient. He further stated that "if the physician is ordering blood the physician should perform the Informed Consent."

Review of a hospital policy titled "Blood Transfusion Procedure", policy number NR-2-6-001, issue date: 04/88, last revised 05/11, presented as current hospital policy, read in part: "Standard of Care. The patient can expect to receive compatible blood for transfusion and be monitored for possible reactions allowing for privacy in a safe and competent manner. Standard of Practice. The RN (Registered Nurse) will administer blood products in a safe and competent manner and allow for patient's privacy. Designated Personnel: RN...Procedure: I. Verify physician's order...IV. B. The Consent and Material Risk Form is signed by the patient and doctor and placed in the patient's chart. The administration of the blood product is not to occur until the consent is signed. In the event the physician is unavailable, such as night time, the Consent and Material Risk form will be dated, timed, and signed by the physician/LIP (licensed independent practitioner within 24 hours...VIII. Place order to TRANSFUSE in the computer system when you are ready to hang blood...1. Verify that a Consent Form has been signed by the patient and doctor and is on the chart. 2. Verify that a MATERIAL RISKS OF TRANSFUSION has been signed by the patient and doctor and is on the chart...X. Obtain vital signs. Record on the Blood Transfusion Flow Sheet: A. The flow sheet MUST STAY ATTACHED TO THE UNIT until completion of transfusion ...1. This will serve as baseline in case the patient has adverse reaction. 2. Vital signs should be taken at the following intervals. a. Prior to transfusion-baseline. b. 15 minutes after start of transfusion. c. Every 30 minutes for duration of transfusion. d. At completion of transfusion. e. One hour post transfusion ..."

Review of a hospital policy titled "Platelet Transfusion Procedure/Care of Patient", policy number NR-2-6-020, issued 04/88, revised/approved date: 05/11, presented as current hospital policy, reads in part: "Standard of Care: The patient/caregiver can expect the patient to receive appropriate platelet infusion or bolus and be monitored privately for possible reactions. Standard of Practice: The RN will administer platelets in a safe, private and competent manner ...Procedure. I. Verify physician's order. I ...b. Verify education and consent forms are on chart. The administration of blood product is not to occur until the consent is signed. In the event the physician is unavailable, such as night time, the Consent and Material Risk form will be dated, timed, and signed by the physician/LIP within 24 [hours]. VII. Obtain vital signs. Record on the Blood Transfusion Flow Sheet: A. The flow sheet MUST STAY ATTACHED TO THE UNIT until completion of transfusion ...1. This will serve as baseline in case the patient has adverse reaction. 2. Vital signs should be taken at the following intervals. a. Prior to transfusion-baseline. b. 15 minutes after start of transfusion. c. Every 30 minutes for duration of transfusion. d. At completion of transfusion. e. One hour post transfusion ..."

Review of a hospital policy titled "Informed Consent", policy number RI-A-030, issued January 15, 1997, last revised 11/11, presented as current hospital policy, revealed: "General Statement. It is our belief that persons have the right to be involved in all aspects of their care. The purpose of this policy is twofold: 1) to insure that a patient's right to be informed and to participate in decision-making is protected and defined, and 2) to insure compliance with applicable federal and state statutes and other regulating bodies. Policy: A. Consent is the voluntary agreement of a person with decision making capacity to make an intelligent choice to do something proposed by another. Informed consent to medical treatment means a consent in writing to any medical or surgical procedures or course of procedures which: 1. Sets forth in general terms the nature of the procedure or procedures, together with known risks...2. Acknowledges that such disclosure of information has been made...3. is signed by the patient for whom the procedure is to be performed...Informed consent is not merely obtaining a signed document. It is an ongoing process that considers the patient's needs and preferences, compliance with institutional policies, the law...B. As a fundamental aspect of the physician/patient relationship and before a patient gives his consent, the physician who will actually perform the medical or surgical procedure must clearly explain to the patient...the following: Source: La. Rev. Stat. Ann. 40:1299.40(A)(1). 1. Nature of pertinent ailment or condition and general nature of proposed treatment or procedure. 2. Potential benefits and known risks...5. Possible results of non-treatment. 6. Risks and benefits of any reasonable therapeutic alternatives...C. A consent form will be completed and executed by the patient or the patient's health care decision maker prior to the performance of any procedures listed in the Louisiana Medical Disclosure Panel's procedures that require Disclosure...E. Surgical and/or Special Consent Forms. These completed forms should be used for the following:..6. When the treating physician determines that the patient will require transfusion(s) of blood and/or blood products...K. Documenting the Consent Given:..4. The names, both of the person giving consent and of those who heard it, must be documented in the medical record...Informed Consent:..3. The attending physician is responsible for verifying the validity of the consent form. This responsibility is not delegated or alleviated by nursing staff documenting the physician's consent conference with the patient by obtaining the patient's signature on the hospital consent form ..."

Review of LA R.S. ?1299.40 revealed the following:

PART XXII. UNIFORM CONSENT LAW

?1299.40. Consent to medical treatment; exception; Louisiana Medical Disclosure Panel; availability of lists to establish necessity and degree. A.(1) Notwithstanding any other law to the contrary, written consent to medical treatment means a handwritten consent to any medical or surgical procedure or course of procedures which: sets forth in general terms the nature and purpose of the procedure or procedures, together with the known risks, if any, of death, brain damage, quadriplegia, [DIAGNOSES REDACTED], the loss or loss of function of any organ or limb, of disfiguring scars associated with such procedure or procedures; acknowledges that such disclosure of information has been made and that all questions asked about the procedure or procedures have been answered in a satisfactory manner; and is signed by the patient for whom the procedure is to be performed, or if the patient for any reason lacks legal capacity to consent by a person who has legal authority to consent on behalf of such patient in such circumstances. Such consent shall be presumed to be valid and effective, in the absence of proof that execution of the consent was induced by misrepresentation of material facts ...B. Except as provided in Subsection A of this Section, no evidence shall be admissible to modify or limit the authorization for performance of the procedure or procedures set forth in such written consent. C. Where consent to medical treatment from a patient, or from a person authorized by law to consent to medical treatment for such patient, is secured other than in accordance with Subsection A above, the explanation to the patient or to the person consenting for such patient shall include the matters set forth in Paragraph (1) of Subsection A above, and an opportunity shall be afforded for asking questions concerning the procedures to be performed which shall be answered in a satisfactory manner. Such consent shall be valid and effective and is subject to proof according to the rules of evidence in ordinary cases (b) Consent to medical treatment may be evidenced according to the provisions of Subsections A and C of this Section or, as an alternative, a physician or other health care provider may choose to avail himself of the lists established by the Louisiana Medical Disclosure Panel pursuant to the provisions of this Subsection as another method by which to evidence a patient's consent to medical treatment ...(3)(a) The Louisiana Medical Disclosure Panel is created within the Department of Health and Hospitals to determine which risks and hazards related to medical care and surgical procedures must be disclosed by a physician or other health care provider to a patient or person authorized to consent for a patient and to establish the general form and substance of such disclosure ...(b) The panel shall prepare separate lists of those medical treatments and surgical procedures that do and do not require disclosure and for those treatments and procedures that do require disclosure shall establish the degree of disclosure required and the form in which the disclosure will be made ...(c) Lists prepared under Subparagraph 4(b) of this Subsection together with written explanations of the degree and form of disclosure shall be promulgated according to the Administrative Procedure Act. The form of the disclosure and manner in which such disclosure will be made shall be subject to legislative oversight by the House and Senate Health and Welfare Committees. The initial lists of the panel shall be published on or before January 1, 1991, or at such time as soon after that date as the panel determines to be feasible, but, in no event, shall the initial lists be published later than March 1, 1991. The lists compiled and published and rules promulgated relative to the form and manner of disclosure according to the provisions of this Subsection and evidence of such disclosures or failure to disclose by a physician or other health care provider as provided in Paragraphs (5) and (6) of this Subsection, shall be admissible in a health care liability suit or medical malpractice claim involving medical care rendered or a surgical procedure performed on or after March 1, 1991 ...(5) Before a patient or a person authorized to consent for a patient gives consent to any medical or surgical procedure that appears on the panel's list requiring disclosure, the physician or other health care provider shall disclose to the patient, or person authorized to consent for the patient, the risks and hazards involved in that kind of care or procedure. A physician or other health care provider may choose to utilize the lists prepared by the panel and shall be considered to have complied with the requirements of this Subsection if disclosure is made as provided in Paragraph (6) of this Subsection ...(6) Consent to medical care that appears on the panel's list requiring disclosure shall be considered effective under this Subsection, if it is given in writing, signed by the patient or a person authorized to give the consent and by a competent witness, and if the written consent specifically states, in such terms and language that a layman would be expected to understand, the risks and hazards that are involved in the medical care or surgical procedure in the form and to the degree required by the panel under Paragraph (4) of this Subsection ...(7)(a) In a suit against a physician or other health care provider involving a health care liability or medical malpractice claim which is based on the negligent failure of the physician or other health care provider to disclose or adequately to disclose the risks and hazards involved in the medical care or surgical procedure rendered by the physician or other health care provider: (i) Both the disclosure made as provided in Paragraph (5) of this Subsection and the failure to disclose based on inclusion of any medical care or surgical procedure on the panel's list for which disclosure is not required shall be admissible in evidence and shall create a rebuttable presumption that the requirements of Paragraphs (5) and (6) of this Subsection have been complied with and this presumption shall be included in the charge to the jury; and (ii) The failure to disclose the risks and ha