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.

GUADALUPE REGIONAL MEDICAL CENTER 1215 E COURT ST SEGUIN, TX 78155 Nov. 15, 2012
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on record review and staff interview, the facility failed to develop a performance improvement plan based on the failure of a process that would ensure documentation of patient allergies in different departments of the hospital would be captured through their electronic documentation system. At exit, the facility did not have a process in place to measure, analyze, and trend data to ensure the process changes in the electronic record system was effective in capturing the documentation of allergies in patient ' s medical record entered from any department in the hospital. There was no current audit of patient medical records to ensure patients did not receive medications that caused an allergic reaction.
Findings included:
This resulted in patient #1 having an allergic reaction to a medication that should have been electronically documented as an allergy.
Record review of Patient #1's History and Physical, completed on 08/04/12 and again on 08/06/12 by Physician #1 (Hospitalist), revealed Patient #1 was allergic to Penicillin, Tetanus Toxoid, Pneumococcal Vaccine, Cipro, and Levaquin.
Record review of Patient #1's History and Physical, completed on 08/05/12 by Physician #2 (Surgeon), revealed Patient #1 was allergic to the previously listed medications.
Record review of Patient #1's handwritten Anesthetic Record, dated 08/06/12 at 1132 AM, revealed she was allergic to Penicillin, Tetanus Toxoid, Cipro, and Levaquin.
Record review of Patient #1's Operative Report, dated 08/06/12 revealed she had a laparoscopic appendectomy and tru-cut liver biopsy on this date.
Record review of an electronic operating room (OR) assessment note, dated 08/06/12 at 1240, revealed Patient #1 was allergic to Cipro, Levaquin, Penicillian, and Tetanus Toxoid.
Record review of a pharmacy order, ordered 08/06/12 at 1249 and discontinued on 08/08/12 at 0827 by Physician #2, revealed he had ordered Levaquin 500 MG Bag/Dextrose 5% in water at a rate of 100 MLS/HR by IV Piggyback for one hour for Patient #1, to be given after her surgical procedure.
Record review of electronic documentation of medications given revealed Patient #1 had received the Levaquin on 08/06/12 at 1504 and again on 08/07/12 at 1039. Patient #1 was in ICU at the time she received the Levaquin. She was transferred to the surgical floor on 08/07/12.
Record review of an electronic nursing note, occurring on 08/08/12 at 0930 and documented at 08/08/12 at 1042, revealed that Patient #1 complained of itching, was medicated per as needed (PRN) orders for the itching, patient reports allergy to Levaquin, allergies updated in computer, Physician #1 was notified and telephone order to discontinue Levaquin was obtained.
Record review of electronic nursing notes, dated from 08/07/12 at 1415 through 08/08/12 at 0750 revealed seven documentations that Patient #1 complained of generalized itching, especially to her face and received PRN medication for the itching. Her face was described as "red and swollen and she had informed nursing staff that was not her norm".
Record review on drugs.com (http://www.drugs.com/sfx/levaquin-side-effects.html) revealed side effects of Levaquin included but was not limited to severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Record review of a facility policy originating in nursing and titled "Patient Allergy Management through Electronic Documentation " , dated 04/2011, revealed the following statement, " Develop a process for obtaining and electronically documenting a complete list of the patient's current allergies upon admission to or before any outpatient service in this organization. Include in this process a method for electronically updating the patient's allergy list with current information at each subsequent visit."
Record review of the facility's Performance Improvement Plan for 2012 revealed the following statement: The Performance Improvement Plan is designed to achieve four goals including but not limited to (2) To pursue opportunites for improving patient safety and customer services by evaluating and analyzing processes associated with patient care. To identify and resolve problems that cause less than optimal patient care or clinical outcome. and (4) To assure appropriate communication, reporting and documentation of all performance improvement and patient safety activities to the Governing Board, hospital administration, medical staff, and appropriate hospital personnel.
Interview on 11/06/12 at 1:45 PM with the facility's Chief Nursing Officer (CNO) revealed she was aware that Patient #1 received two doses of Levaquin. She stated the facility had a "glitch" in their computer system. She stated that although the documentation of Patient #1's allergy to Levaquin was put into the electronic medical records as part of her operating room (OR) assessment, the information failed to propagate over to the other departments (ICU, Surgical Floor, and Pharmacy) who would depend on the electronic medical records to know Patient #1 was allergic to Levaquin. The CNO confirmed Patient #1's allergy to Levaquin was listed on her identification bracelet at the time Patient #1 informed nursing staff on the surgical floor that she was allergic to Levaquin. She stated that the exact date and time that Patient #1's allergy to Levoquin was added to her identification bracelet was unknown. She stated it is believed the allergy was added to her bracelet prior to her surgical procedures. She stated the facility had made some changes to their computer system in order for the allergies to propagate into all areas of electronic documentation. She stated the facility considered this issue a medication error only and did not see it as a process error.
Continued interview on 11/13/12 between 9:20 AM and 12:00 PM with the facility's CNO revealed that nursing staff have the ability to look at the physician's history and physical documentation and it would be her expectation that nursing staff look at these documents when completing a nursing plan of care. She stated the facility does not currently have a process in place for verifying allergies listed on the history and physical completed by the physician. She confirmed that nursing staff should be informing patients what medications they are receiving whether they receive those medications through an IV or orally. She further confirmed that nursing staff should be looking at a patient's identification bracelet every time they administer medications to determine if they have allergies to ordered medications.
She stated nursing staff have been "talked to" about these issues but she confirmed there was no documentation of these discussions.
Continued interview on 11/13/12 in the morning with the facility CNO revealed that none of the changes made in how the allergies were documented in the computer were put in writing, no data has been collected on whether these changes were adequately capturing what medications are documented as allergies, and the changes in this process were not documented and/or discussed as part of their performance improvement plan. She further stated they do not currently have any audit to measure the effectiveness of their process change in regard to documentation of patient allergies into the electronic medical record from all departments of the hospital.
VIOLATION: NURSING CARE PLAN Tag No: A0396
Based on record review and interview with facility staff, the facility failed to ensure that one of one patients (patient #1) had a documented medication allergy included in her initial nursing plan of care. This resulted in patient #1 receiving two doses of the medication and displaying an allergic reaction to the medication.

Findings included:

Record review of Patient #1's History and Physical, completed on 08/04/12 and again on 08/06/12 by Physician #1 (Hospitality), revealed Patient #1 was allergic to Penicillin, Tetanus Toxoid, Pneumococcal Vaccine, Cipro, and Levaquin.

Record review of Patient #1's History and Physical, completed on 08/05/12 by Physician #2 (Surgeon), revealed Patient #1 was allergic to the previously listed medications.

Record review of Patient #1's handwritten Anesthetic Record, dated 08/06/12 at 1132 AM, revealed she was allergic to Penicillin, Tetanus Toxoid, Cipro, and Levaquin.

Record review of Patient #1's Operative Report, dated 08/06/12 revealed she had a laparoscopic appendectomy and tru-cut liver biopsy on this date.

Record review of an electronic operating room (OR) assessment note, dated 08/06/12 at 1240, revealed Patient #1 was allergic to Cipro, Levaquin, Penicillian, and Tetanus Toxoid.

Record review of a pharmacy order, ordered 08/06/12 at 1249 and discontinued on 08/08/12 at 0827 by Physician #2, revealed he had ordered Levaquin 500 MG Bag/Dextrose 5% in water at a rate of 100 MLS/HR by IV Piggyback for one hour for Patient #1, to be given after her surgical procedure.

Record review of electronic documentation of medications given revealed Patient #1 had received the Levaquin on 08/06/12 at 1504 and again on 08/07/12 at 1039. Patient #1 was in ICU at the time she received the Levaquin. She was transferred to the surgical floor on 08/07/12.

Record review of an electronic nursing note, occurring on 08/08/12 at 0930 and documented at 08/08/12 at 1042, revealed that Patient #1 complained of itching, was medicated per as needed (PRN) orders for the itching, patient reports allergy to Levaquin, allergies updated in computer, Physician #1 was notified and telephone order to discontinue Levaquin was obtained.

Record review of electronic nursing notes, dated from 08/07/12 at 1415 through 08/08/12 at 0750 revealed seven documentations that Patient #1 complained of generalized itching, especially to her face and received PRN medication for the itching. Her face was described as "red and swollen and she had informed nursing staff that was not her norm".

Record review of Patient #1's complaint form revealed she was given Levaquin even though it was listed as an allergy on her hospital identification bracelet. She stated she knew she received two doses of the medication. She stated she almost immediately had a "reaction that got worse and worse." She stated she felt as if she was "being boiled in oil and her face especially around her mouth felt scalded." She stated that at one point a nurse brought her a "pill" and she asked about what antibiotic she was getting and the nurse told her Levaquin. She pointed out her allergy to the medication and the nurse told her it was not on her record but when the nurse looked at her identification bracelet, the Levaquin was listed as an allergy."

Record review on drugs.com (http://www.drugs.com/sfx/levaquin-side-effects.html) revealed side effects of Levaquin included but was not limited to severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Record review of a facility policy originating in nursing and entitled "Patient Allergy Management through Electronic Documentation, dated 04/2011, revealed the following statement, " Develop a process for obtaining and electronically documenting a complete list of the patient's current allergies upon admission to or before any outpatient service in this organization. Include in this process a method for electronically updating the patient's allergy list with current information at each subsequent visit."

Interview on 11/06/12 at 1:45 PM with the facility's Chief Nursing Officer (CNO) revealed she was aware that Patient #1 received two doses of Levaquin. She stated the facility had a "glitch" in their computer system. She stated that although the documentation of Patient #1's allergy to Levaquin was put into the electronic medical records as part of her operating room (OR) assessment, the electronic information failed to propagate over to the other departments (ICU, Surgical Floor, and Pharmacy) who would depend on the electronic medical records to know Patient #1 was allergic to Levaquin. The CNO confirmed Patient #1's allergy to Levaquin was listed on her identification bracelet at the time Patient #1 informed nursing staff on the surgical floor that she was allergic to Levaquin. She stated that the exact date and time that Patient #1's allergy to Levoquin was added to her identification bracelet was unknown. She stated it is believed the allergy was added to her bracelet prior to her surgical procedures.

Continued interview on 11/13/12 between 9:20 AM and 12:00 PM with the facility's CNO revealed that nursing staff have the ability to look at the physician's history and physical documentation and it would be her expectation that nursing staff look at these documents when completing a nursing plan of care. She stated the facility does not currently have a process in place for verifying the history and physical completed by the physician. She confirmed that nursing staff should be informing patients what medications they are receiving whether they receive those medications through an IV or orally. She further confirmed that nursing staff should be looking at a patient's identification bracelet every time they administer medications to determine if they have allergies to ordered medications.

She stated nursing staff have been "talked to" about these issues but she confirmed there was no documentation of these discussions.