BROOKE HILL Facility I.D. Number 0035311 Date of Survey:06/27/02 Notice of Violation:08/09/02 Annual Licensure Survey "A" VIOLATION(S): The facilitys governing body shall exercise general direction of the facility, and shall establish the broad policies and procedures for the facility related to its purpose, objectives, operation, and the welfare of the residents served. A registered nurse shall participate, as appropriate, in planning and implementing the training of facility personnel. Medication errors and drug reactions shall be immediately reported to the residents physician and the consulting pharmacist. An entry thereof shall be made in the residents clinical record and the error or reaction shall also be described on an incident report. The facility shall also immediately notify the residents family, guardian, representative, conservator and any private or public agency financially responsible for the residents care whenever unusual circumstances such as accidents, sudden illness, disease, unexplained absences, extraordinary resident charges, billings, or related administrative matters arise. AN OWNER, LICENSEE, ADMINISTRATOR, EMPLOYEE OR AGENT OF A FACILITY SHALL NOT ABUSE OR NEGLECT A RESIDENT. (Sections 2-107 of the Act) A FACILITY ADMINISTRATOR WHO BECOMES AWARE OF ABUSE OR NEGLECT OF A RESIDENT SHALL IMMEDIATELY REPORT THE MATTER BY TELEPHONE AND IN WRITING TO THE RESIDENTS REPRESENTATIVE. (Section 3-610 of the Act) These Regulations are not met. Based on interview and review of facility's incident reports, 10 of 16 clients have had medications errors since 7-14-01, (R4, R5, R6, R7, R8, R9, R11, R12, R13, R14). The governing body has neglected to provide operating direction over the facility to ensure: 1) that the facility implemented their own policies and procedures for the Administration of Medication; 2) that the facility implemented their own policies and procedures on Training and Authorization of Non-Licensed Staff administering medications. The facility failed to provide staff with needed training to ensure that medications are administered without error. Findings Include: 1) Due to facility's failure to implement their own policy and procedure for medication administration, the following medication errors have occurred: 7-14-01, R7: Diagnoses Include: Seizure Disorder and Hiatal Hernia: Prevacid 15 milligrams not given at 8:00 P.M. Staff omitting medication is documented as being E5, (Direct Support Person). 8-23-01, R7: Diagnoses Include: Seizure Disorder and Hiatal Hernia: Tegretol 600 milligrams, Dilantin 120 milligrams, Terazosin 1 milligram, Prevacid 15 milligrams, all not given at 8:00 P.M. Staff omitting medication is documented as being E6, (Direct Support Person). 10-20-01, R5: Diagnoses Include: Partial Complex Seizure Disorder: Tegretol 200 milligrams was given at 6:00 A.M., instead of Tegretol 400 milligrams as ordered. Staff making medication error is documented as being E7, (Direct Support Person). 11-5-01, R8: Diagnoses Include: Epilepsy and Spastic Quadriplegia: Tegretol 600 milligrams was given at 8:00 P.M., instead of Tegretol 200 milligrams as ordered. Staff making medication error is documented as being E7, (Direct Support Person). 11-5-01, R8: Diagnoses Include: Epilepsy and Spastic Quadriplegia: Oyster Calcium D 1500 milligrams was given at 8:00 P.M., instead of Oyster Calcium D 500 milligrams as ordered. Staff making medication error is documented as being E7, (Direct Support Person). 12-18-01, R9: Diagnoses Include: Hypothyroidism: Synthroid 0.112 milligrams was ordered for 6:00 A.M.. Was given 6:00 A.M. dose and again at 8:00 P.M., instead of Zyprexa 5 milligrams, at 8:00 P.M., as ordered. Zyprexa 5 milligrams not given on 12-18-01 as ordered. Staff making medication error is documented as being E6, (Direct Support Person). 1-25-02, R11: Diagnoses Include: Cerebral Palsy, Spastic Quadriparesis, Contractures of lower extremities, (severe), and contractures of upper extremities, (moderate): Oyster Calcium D, 500 milligrams not given at 8:00 P.M. as ordered. Staff omitting medication is documented as being E8, (Direct Support Person). 1-26-02, R11: Diagnoses Include:Cerebral Palsy, Spastic Quadriparesis, Contractures of lower extremities, (severe), and contractures of upper extremities, (moderate): Oyster Calcium D, 500 milligrams not given at 8:00 P.M. as ordered. Staff omitting medication is documented as being E4, (Direct Support Person). 1-27-02, R11: Diagnoses Include:Cerebral Palsy, Spastic Quadriparesis, Contractures of lower extremities, (severe), and contractures of upper extremities, (moderate): Oyster Calcium D, 500 milligrams not given at 8:00 P.M. as ordered. Staff omitting medication is documented as being E4, (Direct Support Person). 2-3-02, R4: Diagnoses Include: Seizure Disorder: Depakote 750 milligrams and Dilantin 130 milligrams not given at 8:00 P.M. as ordered. Staff omitting medication is documented as being E4, (Direct Support Person). 2-4-02, R4: Diagnoses Include: Seizure Disorder: Depakote 750 milligrams and Dilantin 130 milligrams not given at 8:00 P.M., as ordered. Staff omitting medication is documented as being E4, (Direct Support Person). 3-19-02, R14: Diagnoses Include: Gastro-Esophogeal Reflux Disease and S/P Colon Surgery: Relafen 500 milligrams, 2 tablets given at 6:00 A.M., instead of 1 tablet as ordered. Staff making medication error is documented as being E9, (Direct Support Person). 4-11-02, R12: Diagnoses Include: Hiatal Hernia and Diverticula: Was given another resident's medication, Tegretol 200 milligrams, and Oyster Calcium D 500 milligrams at 4:30 P.M.. Staff making medication error is documented as being E10, (Direct Support Person). 5-13-02, R5: Diagnoses Include: Partial Complex Seizure Disorder: Was given Tegretol 200 milligrams at 6:00 A.M., instead of 400 milligrams as ordered. Staff making medication error is documented as being E11, (Direct Support Person). 5-14-02, R5: Diagnoses Include: Partial Complex Seizure Disorder: was given Tegretol 200 milligrams at 6:00 A.M., instead of 400 milligrams as ordered. Staff making medication error is documented as being E9, (Direct Support Person). 5-15-02, R4, Diagnoses Include: Seizure Disorder: Depakote 250 milligrams not given at 4:00 P.M., as ordered. 5-17-02, R4, Diagnoses Include: Seizure Disorder: Depakote 250 milligrams not given at 4:00 P.M., as ordered. 6-9-02, R13: Diagnoses Include: Spastic Quadriplegia, (Severe Hypotonicity and Flexion Contractures): Was given Lorazepam 2 milligrams at 4:00 P.M., instead of Diazepam 4 milligrams as ordered. Staff making medication error is documented as being E10, (Direct Support Person). Per interview with E3, Registered Nurse/Trainer, on 6-19-02, at 1:30 P.M., E3 stated that she did not think that any of the above medication errors were significant, because they had not caused any adverse effects. Per interview with E3, Registered Nurse/Nurse Trainer, on 6-19-02, at 9:25 A.M., E3 stated that she was aware of all the medication errors, and that as a nurse, she does not feel comfortable with them. E3 continued to say that she had no system in place to monitor staff making the medication errors, except to look at the incident reports. Per interview with E1, Administrator, on 6-19-02, at 9:45 A.M., E1 stated that he was aware of the large amount of medication errors, but that he had left it up to E3, Registered Nurse/Nurse Trainer, to inservice and retrain staff as needed. E1 continued to say that he should have monitored the medication errors and had staff re-trained on medication administration, but had not. Per interview with E1 on 6-19-02, at 2:00 P.M., E1 stated that he felt that all of the medication errors were significant errors and that the Direct Support Staff should have been retrained, "at the very least." E1 continued to say that he does not feel that E3 took enough action regarding the medication errors, and that he is making a new policy for staff and medication errors. 2) The facility has failed to implement their own policy and procedures for Training and Authorization of Non-Licensed staff administering medications. The facility has also failed to provide staff with needed training to ensure medications are administered without error. Per review of facility's policy and procedure on Administration of Medication: Section V states, "Medications prescribed for one resident will not be administered to another resident." Per record review, R12 is a 76 year old male that functions at a severe level of mental retardation. Other Diagnoses include: Hiatal Hernia and Diverticula. Per review of facility's "Medication Error Report", dated 4-12-02, surveyor noted that on 4-11-02, R12 was given another resident's medication. Medication included: Tegretol 200 milligrams and Oyster Calcium D 500 milligrams at 4:30 P.M.. Staff making the medication error is documented as being E10, Direct Support Person. Section VII states, "Medication errors and drug reactions will be immediately reported to the resident's physician and the consulting pharmacist. An entry thereof will be made in the resident's clinical record and the error or reaction will also be described on an incident report." Per review of facility's "Seizure Documentation Record", for R4, surveyor noted that on 5-29-02, R4 had a seizure at 12:30 A.M.. Documentation also states that she had another seizure at "unknown" time. Documentation as to trigger of seizure; "missed two 4 P.M. doses of Depakote 250 mg. (milligrams) on the 15th and 17th of May." Per review of R4's Nurses Notes, surveyor noted no documentation had been entered into the Nursing Notes regarding the missed doses of seizure medication for either 5-15-02, not 5-17-02. Per interview with E3, Registered Nurse/Trainer, on 6-19-02, at 1:30 P.M., E3 confirmed no documentation in Nurses Notes regarding R4's missed doses of seizure medication on 5-15-02 and 5-17-02. E3 continued to say, "I haven't been documenting on nurses notes like I should have been." E3 then stated that if a medication error has no adverse effects, then the physician is not notified. Per interview with Z5, Neurologist, on 6-21-02, at 3:00 P.M., via telephone, Z5 stated that she was not notified of any of the medication errors pertaining to R4 not receiving her anticonvulsants. Z5 also stated that missed doses of the anticonvulsant medication would have contributed to R4 having seizures. Z5 continued to say that had she known about the medication errors, she would not have increased the dosage of Depakote, but would have told the facility to be compliant with her (R4's) medication. Other examples of medication errors documented on facility's "Medication Error Report" or "Seizure Documentation Record", but no documentation in the Nurses Notes are available for: R4 --- 2-3-02 and 2-4-02 R5 --- 10-20-01, 5-13-02, and 5-14-02 R7 --- 7-14-01 and 8-23-01 R9 --- 12-18-01 R11 -- 1-25-02, 1-26-02, and 1-27-02 R13 -- 6-9-02 R14 -- 3-19-02 The facility has failed to provide staff with needed training to ensure that medications are administered without error. Per review of facility's policy and procedure on "Training and Authorization on Non-Licensed Staff", the policy and procedure states: "Authorized direct support persons will be re-evaluated by a nurse-trainer at least annually or more frequently at the discretion of the registered professional nurse. Annual training will include the theory (&) and best practice standards of medication administration. Any retraining will be to the extent that is necessary to ensure competency of such authorized direct support persons to administer medication, as judged by the nurse-trainer." Per interview with E3, Registered Nurse/Trainer, on 6-19-02, at 9:25 A.M., at the facility, E3 stated that she had not yet done the annual training of any of the direct support staff on medication administration. E3 said, "I just got the paper not too long ago for it to be done." E3 stated that she was not aware of the facility's policy stating that retraining in medication administration was to be done annually. Per Interview with E1, Administrator, on 6-20-02, at 10:50 A.M., E1 informed surveyor that there are currently 8 direct support staff that are trained in medication administration. E1 continued to say, that out of the 8 persons that are trained in medication administration, 3 direct support persons' training has not been completed annually as per facility policy. E14 (Direct Support Person) -- last documented training 12-00. E6 (Direct Support Person) -- last documented training 12-1-00. E11 (Direct Support Person -- last documented training 1-8-01. Per interview with E3, Registered Nurse/Nurse Trainer, on 6-19-02, at 9:25 A.M., E3 stated that she was aware of all the medication errors, and that as a nurse, she does not feel comfortable with them. E3 continued to say that she had no system in place to monitor staff making the medication errors, except to look at the incident reports. Per interview with E1, Administrator, on 6-19-02, at 9:45 A.M., E1 stated that he was aware of the large amount of medication errors, but that he had left it up to E3, Registered Nurse/Nurse Trainer, to inservice and retrain staff as needed. E1 continued to say that he should have monitored the medication errors and had staff re-trained on medication administration, but had not. Per interview with E1 on 6-19-02, at 2:00 P.M., E1 stated that he felt that all of the medication errors were significant errors and that the Direct Support Staff should have been retrained, "at the very least." E1 continued to say that he does not feel that E3 took enough action regarding the medication errors, and that he is making a new policy for staff and medication errors. Based on observation, interview and record verification, the facility has failed to notify client's guardians of incidences of medication errors and changes in client's medications for 2 of 5 clients in the sample (R4, R5) and 8 clients outside the sample (R6, R7, R8, R9, R11, R12, R13, R14). Findings Include: 1. Per record verification, R4 is a 41 year old female who functions at a Profound level with diagnoses that include Seizure Disorder and Hypothyroidism. R4 is prescribed Depakote 750 mg three times daily and Dilantin 130 mg twice daily for seizure control. Per record verification of the facility's Medication Error Report form dated 02-06-02, errors were made in dispensing R4's Depakote and Dilantin medication on 02-3-02 and 02-04-02 at the 8:00 P.M. medication passes: "DSP assisting in med pass failed to give 8:00 P.M. medication." Surveyor noted the Seizure Documentation record of the facility for R4, dated 05-29-02 to state, "Missed two 4:00 P.M. doses of Depakote 250 mg on the 15th and 17th of May" and the question on the form that asked for "any known seizure triggers present" had circled "missed medication". Per interview with Z2, Office of State Guardianship and guardian of R4 on 06-20-01 at 2:00 P.M. by telephone, when asked if she was notified of the errors with R4's medications, she stated, "No, I don't believe I was. I was definitely not notified of any medications missed in May and I can find nothing to indicate I was notified of medications being missed in February. I would expect to be notified of medication errors." 2. R6 is a 45 year old female who functions at a Moderate level with diagnoses that include Seizure Disorder, Down's Syndrome and Physiologic Mega Colon. R6 is prescribed Prevacid, Reglan and Simethicone for her physical symptoms related to the Mega Colon. Per record verification of the facility Medication Error Report of 06-18-02, an error was made in administering R6's medications of 06-15-02, 06-16-02 and 06-18-02. The order for R6's medication read, "Simethicone, 80 mg, Chew 2 tablets by mouth after meals and bedtime." Per interview with E3, Registered Nurse, (RN) on 06-19-02 at 10:00 A.M. at the facility, "R6 went into the hospital Sunday morning complaining of dizziness and had low blood pressure. Staff called and said she was pale and dizzy. She was admitted with dehydration. Last night staff called and said there was a medication error for (R6). She got Seroquel, 400 mg Saturday night at 8:00 P.M., Sunday morning at 6:00 A.M. and again last night." Per interview with Z4, guardian of R6 on 06-20-02 at 2:50 P.M. by telephone, she was informed that R6 went to the hospital for dizziness, low blood pressure and dehydration but "they never mentioned anything about a wrong medication being given to her." She feels that she should have been notified. Per interview with E1, Administrator on 06-21-02 at 9:45 A.M. at the facility, when asked of any of the client's who had medication errors guardians were notified of the errors, he stated, "I can't say that I'm aware of any guardians being notified of medication errors." Based on interview and record verification the facility has neglected to provide nursing services in the area of 1. in-service, training and monitoring of non-licensed staff, 2. monitoring clients physical status, 3. communication of significant events to the physician, 4. documentation of significant events and 5. insuring accuracy of medications received from the pharmacy for 2 of 5 clients in the sample (R4, R5) and 8 clients outside the sample (R6, R7, R8, R9, R11, R12, R13, R14) with the potential to affect all. Findings Include: 1. Providing In-service, Training and Monitoring of Non-Licensed Staff Per review of facility's incident reports and Seizure Documentation records, the surveyor noted that from 7-14-01 through 6-20-02, the facility has recorded 21 incidents of medication errors. Per continuing review of the incident reports, 10 of the facility's 16 clients have had one or more medication errors within the last 11 months. Surveyor also noted that documentation of staff making medication errors indicated that 9 different staff were responsible for the errors. Per interview with E3, Registered Nurse/Nurse Trainer, on 6-19-02, at 9:25 A.M., E3 stated that she was aware of all the medication errors, and that as a nurse, she does not feel comfortable with them. E3 continued to say that she had no system in place to monitor staff making the medication errors, except to look at the incident reports. Per interview with E3, on 6-19-02, at 9:10 A.M., E3 stated that if direct support person makes a significant error that causes adverse reaction to the resident, then the direct support persons would be re-trained on medication administration. E3 continued to say, that if the resident does not have a adverse reaction, then she (E3) in-services them verbally. E3 stated that she talks to them about the medication error, sometimes by telephone, so she has no documentation that in-servicing has occurred. Per continuing interview with E3, at above date and time, E3 stated that she has not had any staff that she felt needed re-training, that she "just told them that they could not make mistakes passing meds." Per interview with E3, on 6-19-02, at 9:25 A.M., at the facility, E3 stated that she had not yet done the annual training any of the direct support staff on medication administration. E3 said, "I just got the paper not too long ago for it to be done." E3 stated that she was not aware of the facility's policy stating that retraining in medication administration was to be done annually. Per Interview with E1, Administrator, on 6-20-02, at 10:50 A.M., E1 informed surveyor that there are currently 8 Direct Support Staff that are trained in medication administration. E1 continued to say, that out of the 8 persons that are trained in medication administration, 3 Direct Support Persons' training has not been completed annually as per facility policy. (E14 -- last documented training 12-00; E6 -- last documented training 12-1-00; E11 -- last documented training 1-8-01). Per interview with E1, Administrator, on 6-19-02, at 9:45 A.M., E1 stated that he was aware of the large amount of medication errors, but that he had left it up to E3, Registered Nurse/Nurse Trainer, to in-service and retrain staff as needed. E1 continued to say that he should have monitored the medication errors and had staff re-trained on medication administration, but had not. Per interview with E1 on 6-19-02, at 2:00 P.M., E1 stated that he felt that all of the medication errors were significant errors and that the Direct Support Staff should have been retrained, "at the very least." E1 continued to say that he does not feel that E3 took enough action regarding the medication errors, and that he is making a new policy for staff and medication errors. 2. Failure to monitor client's physical status. Per interview with E3, on 6-19-02, at 1:30 P.M., E3 stated that if a medication error is made, Direct Support Person is to contact her (E3), as soon as they can. E3 then tells them to get the client's vital signs and observe them. E3 continued to say that the Direct Support Persons do not document the client's vital signs or observations, "they write the vital signs on a note and stick it on my door. I look at them for a few days - at least 24 hours - and see that it's okay, then I throw them away." E3 confirmed that no record of vital signs and monitoring of clients condition after a medication error was documented anywhere. E3 also stated, "I haven't been documenting on Nurses Notes like I should have been. 3. Failure to Communicate significant events to the physician. Per record verification, R4 is a 41 year old female who functions at a Profound level with diagnoses that include Seizure Disorder and Hypothyroidism. R4 is prescribed Depakote 750 mg three times daily and Dilantin 130 mg twice daily for seizure control. Per record verification of the facility's Medication Error Report form dated 02-06-02, errors were made in dispensing R4's Depakote and Dilantin medication on two occasions, 02-3-02 and 02-04-02 at the 8:00 P.M. medication passes: "DSP assisting in med pass failed to give 8:00 P.M. medication." The report indicated that the Administrator, Director of Nursing and Physician were notified. Review of the facility Seizure Record for R4 indicates that she had 2 seizures on 02-05-02, at 1:30 A.M. and again at 4:00 P.M. Further review of the facility seizure records indicates that R4 had another seizure on 02-07-02 at 1:30 A.M. While reviewing the clinical record for R4, surveyor noted further instances of seizure activity associated with medication errors where anticonvulsant medication was not given. Surveyor noted the Seizure Documentation record of the facility for R4, dated 05-29-02 to state, "Missed two 4:00 P.M. doses of Depakote 250 mg on the 15th and 17th of May" and the question on the form that asked for "any known seizure triggers present" had circled "missed medication". No other documentation of these medication errors could be found either in the facility nurses notes or the facility Medication Error Report form. Per record verification of facility nurses notes of 02-05-02 The facility was in contact with Z5, Neurologist on 02-05-02 after the medication errors and the seizures occurring with R4. The entry in the nurses notes reads: " (Z5) gave orders to increase Depakote to 750 mg TID (three times daily) ." Per review of the facility physician Progress Notes of 02-20-02 written by Z5, Neurologist, R4 was seen by the neurologist on that date and the physician noted R4 to have had "4 seizures since last visit, 1 in January and 3 in February, noted at night time." Z5 reviewed the seizure history at that time and noted the Depakote level drawn 01-20-02 to be below therapeutic level at 43 and also noted medication had been increased since the level was drawn. Per interview with Z5 on 06-21-02 at 3:00 P.M. by telephone, Z5 was asked "Were you notified of the medication errors pertaining to R4 and that she was not receiving all her prescribed anticonvulsant medication during the period of time in February when she was having seizures?" Z5 replied, "No, I was not notified." Z5 was asked, do you think the missed doses of anticonvulsant medication contributed to the seizure activity and the sub-therapeutic Depakote levels. Z5 replied, "Yes, it would." Z5 was asked, "Would you have increased the Depakote medication if you had known the client was not getting her medication as prescribed? Z5 stated, "No. I would have told them to be compliant with her medication." 4. Failure to document medication errors Per verification, R4 is a 41 year old female who functions at a Profound level with diagnoses that include Seizure Disorder and Hypothyroidism. R4 is prescribed Depakote 750 mg three times daily and Dilantin 130 mg twice daily for seizure control Per record verification of the facility's Medication Error Report form dated 02-06-02, errors were made in dispensing R4's Depakote and Dilantin medication on two occasions, 02-3-02 and 02-04-02 at the 8:00 P.M. medication passes: "DSP assisting in med pass failed to give 8:00 P.M. medication." While reviewing the clinical record for R4, surveyor noted further instances of seizure activity associated with medication errors where anticonvulsant medication was not given. Review of seizure records of 05-29- 02 and 05-30-02 indicate that R4 had 2 seizures on 05-29-02, one at 12:30 A.M. and one at approximately 7:35 A.M. (exact time not stated) and 2 seizures on 05-30-02, one at 12:00 A.M. and one at 3:30 A.M. Surveyor noted the Seizure Documentation record of the facility for R4, dated 05-29-02 to state, "Missed two 4:00 P.M. doses of Depakote 250 mg on the 15th and 17th of May" and the question on the form that asked for "any known seizure triggers present" had circled "missed medication". No other documentation of these medication errors could be found either in the facility nurses notes or the facility Medication Error Report form. Per review of facility policy on medication errors, the policy states: "1. In the event of a medication error, authorized direct support persons will immediately report the error to their supervisor and registered nurse to receive direction on any action to be taken." "2. All medication errors will be documented in the individual's clinical record and a medication error report will be completed within the time frames specified." Per surveyor review of Medication error reports filed in the facility Incident/Accident book the facility neglected to document the medication errors of May 15, 2002 and May 17, 2002 either on the Medication error form or in the clients's clinical record and those errors were found by surveyors during record review. The errors were not reported to the physician or to the Department of Public Health per facility policy. Per surveyor review of facility nurses notes during the course of the survey, the facility has neglected to document 13 of the 21 medication errors in any of the clinical records of clients receiving the 21 medication errors. Per interview with E1, Administrator, on 06-21-02, when asked if he had been able to find any medication error reports regarding the above error to R4 on May 15, 2002 and May 17, 2002 he stated, "No, I have not. I've looked, but I cannot find anything regarding those errors." 5. Failure to ensure the accuracy of medications provided by the pharmacy. R6 is a 45 year old female who functions at a Moderate level with diagnoses that include Seizure Disorder, Down's Syndrome and Physiologic Mega Colon. R6 is prescribed Prevacid (antiulcer medication), Reglan (a medication to speed up gastric emptying) and Simethicone(a medication for excess gas) for her physical symptoms related to the Mega Colon. Per interview with E3, Registered Nurse, (RN) on 06-19-02 at 10:00 A.M. at the facility, "R6 went into the hospital Sunday morning (06/16/02) complaining of dizziness and had low blood pressure. Staff called and said she was pale and dizzy. She was admitted with dehydration. Last night staff called and said there was a medication error for (R6). She got Seroquel 400 mg (a medication that was not prescribed for R6) Saturday night at 8:00 P.M., Seroquel 400 mg Sunday morning at 6:00 A.M. and again last night (Tuesday, after she returned from the hospital). Per record verification of the facility Medication Error Report of 06-18-02, an error was made in administering R6's medications of 06-15-02, 06-16-02 and 06-18-02. The order for R6's medication read, "Simethicone, 80 mg, Chew 2 tablets by mouth after meals and bedtime." Per observation of the bubble pack containing R6's medication, the pack was labeled as Simethicone, 80 mg, with the above instructions on the label. On the left side of the bubble pack, directly above the first tablet, "Seroquel 200 mg. tab" was written. E3 further stated,"I check the medications when they come from the pharmacy but I usually just check the bubble packs for the correct number of pills. I don't check the medications individually for accuracy. I, myself would probably not have noticed this." Per observation of the bubble pack on 06-19-02 at 10:00 A.M., there are 6 Seroquel 200 mg tablets missing from the pack. Per interview with Z6, Pharmacist on 06-21-02 at 3:15 P.M., by telephone, when asked if he had spoken with E3 about the error, he stated, "Yes. The card was labeled Seroquel. The tablets are different. It should have been noticed before it was given." Per interview with E1, Administrator on 06-19-02 at 6:00 P.M. at the facility, when discussing the Seroquel bubble pack, he stated, "I'm not a nurse but I can see the pack says Seroquel and even the tablets say Seroquel." Based on interview and review of facility records, the facility has neglected to ensure that all medications are administered in compliance with physician's orders for 2 of 5 clients in the sample (R4 and R5) and 8 outside the sample ( R6, R7, R8, R9, R11, R12, R13, R14). The facility has neglected to take necessary action to protect the individuals and prevent recurrence. Based on interview and record verification, the facility has failed to ensure that all medications are administered without error for 10 of 16 clients in the facility, (R4, R5, R6, R7, R8, R9, R11, R12, R13, R14). Findings Include: Per review of facilities incident reports, and Seizure Documentation records, it was noted that 21 medication errors have occurred since 7-14-01, involving 10 of the 16 clients in the facility. Surveyor also noted that the medication errors involved 9 different staff persons that had administered the medications. 1. Per record verification, R4 is a 41 year old female that functions at a profound level of mental retardation. Diagnoses include Seizure Disorder. Per review of R4's Physician's Order Sheet, dated 6-16-02 through 7-15-02, Medications ordered for R4's Seizure's include: Depakote 250 milligrams three times a day; Depakote 500 milligrams three times a day; Dilantin 100 milligrams twice a day; Dilantin 30 milligrams twice a day. Per review of facility's incident report, dated 2-6-02, surveyor noted that on 2-3-02 and 2-4-02, R4 had not been given her 8:00 P.M. seizure medications (Depakote 750 milligrams, and Dilantin 130 milligrams). Staff documented as omitting the 8:00 P.M. seizure medications on 2-3-02 and 2-4-02 was E4, (Direct Support Person). Per review of R4's Nurse's Notes dated 2-5-02, documentation states, "Seizure @ (at) 1:30 A.M. Another at 4:00 P.M. on bus." Per continuing review of R4's Nurse's Notes dated 2-7-02, documentation states, "Had seizure lasting 5 minutes. Right side of body remained limp." Documentation in Nurse's Notes dated 2-5-02, also states, "(Late Entry) Z5, (Neurologist), gave order to increase Depakote to 750 mg. (milligrams) TID (three times a day). This is additional 250 mg. (milligrams) dly (daily)." Per review of facility's "Seizure Documentation Record" for R4, surveyor noted that on 5-29-02, R4 had a seizure at 12:30 A.M.. Documentation also states that she had another seizure at "unknown" time. Documentation as to trigger of seizure; "missed two 4 P.M. doses of Depakote 250 mg. (milligrams) on the 15th and 17th of May." Per interview with Z5, Neurologist, on 6-21-02, at 3:00 P.M., via telephone, Z5 stated that she was not notified of any of the medication errors pertaining to R4 not receiving her anticonvulsants. Z5 also stated that missed doses of the anticonvulsant medication would have contributed to R4 having seizures. Z5 continued to say that had she known about the medication errors, she would not have increased the dosage of Depakote, but have told the facility to be compliant with her (R4's) medication. Per interview with Z3, Pharmacist, on 6-20-02, at 2:03 P.M., via telephone, regarding R4 missing doses of Depakote, Z3 stated that it "would be a very likely possibility that missing these doses, especially consecutive doses, would be the cause of those seizures." 2. Per record verification, R6 is a 45 year old female that functions at a moderate level of mental retardation. Diagnoses include: Physiologic Mega Colon. On 6-18-02, at time of entrance to facility for annual survey, E1 informed surveyor that R6 was in a local hospital with dehydration, low blood pressure, and dizziness. R6 had been admitted to the hospital on 6-16- 02. On 6-18-02, R6 was released from the hospital and returned to the facility. On 6-19-02, E1 informed surveyor that there had been a medication error regarding R6. Medication was ordered as "Simethicone 80 mg. (milligrams), two tablets by mouth after meals and bedtime." Per review of "Medication Error Report", R6 was given Seroquel 200 milligrams, 2 tablets, on 6-15-02, at 8:00 P.M., 6-16-02, at 6:00 A.M., and 6-18-02, at 6:00 P.M., instead of Simethicone as ordered. Per review of Medication card sent from pharmacy, the label states, "Simethicone 80 mg. (milligrams). At the top of the bubble pack, medication card is labeled as "Seroquel 200 mg. (milligrams) tablet." Per interview with E3, Registered Nurse, on 6-19-02, at 10:00 A.M., E3 stated that on 6-15-02, at 8 P.M., R6 was administered Seroquel 200 milligrams (2 tablets for a total of 400 milligrams), instead of Simethicone 80 milligrams (2 tablets) as ordered. E3 stated that on 6-16-02, at 6:00 A.M., R6 was again given Seroquel 400 milligrams instead of Simethicone. R6 became dizzy, and had low blood pressure. R6 was admitted to the hospital with a diagnosis of dehydration. Per review of facility's "Medication Error Report", dated 6-19-02, description of error is documented as, "DSP (Direct Support Person) gave 6 P.M. dose of what she believed to be Simethicone 80 mg. (milligrams). After giving the pills and looking back over card noticed packaged in card was Seroquel 200 mg. (milligrams)." Per interview with E3, on 6-19-02, at 10:00 A.M., E3 stated that E1, Administrator, had called her last night (6-18-02) to tell her about the medication error. E3 continued to say, "I myself would probably not have noticed this." E3 also stated that she was the person that checked the medication when it was delivered from the pharmacy. Per interview with Z3, Pharmacist, on 6-20-02, at 2:03 P.M., in regards to R6 being administered Seroquel instead of Simethicone, Z3 stated that it was a "very good possibility that the medication is what caused the hospitalization." Per interview with Z6, Pharmacist, on 6-21-02, at 3:15 P.M., in regards to R6 being administered Seroquel instead of Simethicone, Z6 stated, "The card was labeled Seroquel, the tablets are different and should have been noticed before it was given." When asked if being administered Seroquel instead of Simethicone could have caused R6 to be hospitalized, Z6 replied, "I would think." Per interview with Z7, R6's Physician, on 6-25-02, at 11:25 A.M., Z7 stated that he did not know if taking Seroquel instead of Simethicone would have contributed to R6's hospitalization on 6-16-02 or not. Z7 continued to say, "she's on Zyprexa also, so it might have had something to do with it. She got 50 milligrams right?" Surveyor informed Z7 that R6 had been administered 400 milligrams on three different occasions. Z7 replied, "that's quite a large dose." Documentation for medication errors are also available for: 7-14-01, R7: Diagnoses Include: Seizure Disorder and Hiatal Hernia: Prevacid 15 milligrams not given at 8:00 P.M. Staff omitting medication is documented as being E5, (Direct Support Person). 8-23-01, R7: Diagnoses Include: Seizure Disorder and Hiatal Hernia: Tegretol 600 milligrams, Dilantin 120 milligrams, Terazosin 1 milligram, Prevacid 15 milligrams, all not given at 8:00 P.M. Staff omitting medication is documented as being E6, (Direct Support Person). 10-20-01, R5: Diagnoses Include: Partial Complex Seizure Disorder: Tegretol 200 milligrams was given at 6:00 A.M., instead of Tegretol 400 milligrams as ordered. Staff making medication error is documented as being E7, (Direct Support Person). 11-5-01, R8: Diagnoses Include: Epilepsy and Spastic Quadriplegia: Tegretol 600 milligrams was given at 8:00 P.M., instead of Tegretol 200 milligrams as ordered. Staff making medication error is documented as being E7, (Direct Support Person). 11-5-01, R8: Diagnoses Include: Epilepsy and Spastic Quadriplegia: Oyster Calcium D 1500 milligrams was given at 8:00 P.M., instead of Oyster Calcium D 500 milligrams as ordered. Staff making medication error is documented as being E7, (Direct Support Person). 12-18-01, R9: Diagnoses Include: Hypothyroidism: Synthroid 0.112 milligrams was ordered for 6:00 A.M.. Was given 6:00 A.M. dose and again at 8:00 P.M., instead of Zyprexa 5 milligrams, at 8:00 P.M., as ordered. Zyprexa 5 milligrams not given on 12-18-01 as ordered. Staff making medication error is documented as being E6, (Direct Support Person). 1-25-02, R11: Diagnoses Include: Cerebral Palsy, Spastic Quadriparesis, Contractures of lower extremities, (severe), and contractures of upper extremities, (moderate): Oyster Calcium D, 500 milligrams not given at 8:00 P.M. as ordered. Staff omitting medication is documented as being E8, (Direct Support Person). 1-26-02, R11: Diagnoses Include:Cerebral Palsy, Spastic Quadriparesis, Contractures of lower extremities, (severe), and contractures of upper extremities, (moderate): Oyster Calcium D, 500 milligrams not given at 8:00 P.M. as ordered. Staff omitting medication is documented as being E4, (Direct Support Person). 1-27-02, R11: Diagnoses Include:Cerebral Palsy, Spastic Quadriparesis, Contractures of lower extremities, (severe), and contractures of upper extremities, (moderate): Oyster Calcium D, 500 milligrams not given at 8:00 P.M. as ordered. Staff omitting medication is documented as being E4, (Direct Support Person). 3-19-02, R14: Diagnoses Include: Gastro-Esophogeal Reflux Disease and S/P Colon Surgery: Relafen 500 milligrams, 2 tablets given at 6:00 A.M., instead of 1 tablet as ordered. Staff making medication error is documented as being E9, (Direct Support Person). 4-11-02, R12: Diagnoses Include: Hiatal Hernia and Diverticula: Was given another resident's medication, Tegretol 200 milligrams, and Oyster Calcium D 500 milligrams at 4:30 P.M.. Staff making medication error is documented as being E10, (Direct Support Person). 5-13-02, R5: Diagnoses Include: Partial Complex Seizure Disorder: Was given Tegretol 200 milligrams at 6:00 A.M., instead of 400 milligrams as ordered. Staff making medication error is documented as being E11, (Direct Support Person). 5-14-02, R5: Diagnoses Include: Partial Complex Seizure Disorder: was given Tegretol 200 milligrams at 6:00 A.M., instead of 400 milligrams as ordered. Staff making medication error is documented as being E9, (Direct Support Person). 6-9-02, R13: Diagnoses Include: Spastic Quadriplegia, (Severe Hypotonicity and Flexion Contractures): Was given Lorazepam 2 milligrams at 4:00 P.M., instead of Diazepam 4 milligrams as ordered. Staff making medication error is documented as being E10, (Direct Support Person). Per interview with E3, on 6-19-02, at 1:30 P.M., E3 stated that she did not think that any of the above medication errors were significant, because they had not caused any adverse effects. |