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Based on medical record review and interview the facility failed to provide a copy of an "Important Message from Medicare" (IMM) to 5 out of 9 patients (#12,#17,#18, #36 and #40), which could potentially deprive patients of the information necessary to exercise their rights. Findings include:

On 09/10/12 at approximately 1100, during record review of patient #17's, chart it was revealed that the patient was admitted on 09/06/12 and document titled "An Important Message From Medicare About Your Right" had the patient's signature, but lacked a signature date.

On 09/10/12 at approximately 1130 during record review of patient #18's, chart it was revealed that the patient was admitted on 09/07/12 and document titled "An Important Message From Medicare About Your Right" was not signed until 09/10/12 which was past the 48 hour required time frame.

On 9/10/12 at approximately 1140 during an interview with staff L it was confirmed that patient #17 did not date the IMM, and patient #18 did not sign the IMM within the 48 hour time frame.


28273

During review of the medical record for patient #36 on 09/10/2012 at 1430, it revealed that the patient had been admitted to the 5 th floor medical/surgical unit of the hospital on 09/07/2012. The Important Message from Medicare (IMM) had not been given to the patient at the time of the record review.

During an interview with staff AT on 09/10/2012 at 1430, she confirmed the findings and stated "there should be one on the chart; they are supposed to be completed within 48 hours of admission."

During review of the medical record for patient #40 on 09/10/2012 at 1630, it revealed that the patient had been admitted to the 6 th floor medical/surgical unit on 09/07/2012. The IMM was not completed on the patient until 09/10/2012.

During an interview with staff AJ on 09/10/2012 at 1630 she confirmed the findings and stated that "the IMMs are supposed to be completed within 48 hours of the patient being admitted."



29955

On 9/10/2012 at approximately 1025 AM during review of patient # 12 it was revealed the patient did not receive the document "An Important Message from Medicare" within the 48 hours of admission to the hospital on 9/4/2012 and the medical record was absent of any documentation of the "Important Message from Medicare". An interview with staff AS confirmed the "Important Message from Medicare" was not in the patient's chart and when asked what the requirement for providing the "Important Message from Medicare" staff AS stated within 48 hours of admission.

Based on medical record review and interview the facility failed to ensure that the administration of scheduled medications were documented on the medication administration record for 2 of 14 patient's (#12 and #55) resulting in the potential for hypertension and infection. Findings include:

On 9/10/2012 at approximately 10:45 am during medical record review of patient # 12's medication administration record it was noted the medication hydralazine 25 mg was not administered to the patient as ordered at 0500 on 9/6/2012 and 9/7/2012. An order to discontinue or not dispense the medication was not found in the chart.

On 9/10/2012 at approximately 1045 during an interview with staff AT it was confirmed that the medication had not been dispensed as ordered and stated that a note should have been made if the patient had refused the medication, but at the time of review of the chart no note could be found why the medication had been missed.

On 9/12/2012 at approximately 10:35 am during the medical record review of patient #55's medication administration record it was noted the medication sucralfate suspension 10 ml was not dispensed as ordered at 1700 on 2/12/2012. Further review of the medication administration records revealed the following medications were not dispensed as ordered: Famotidine 20 mg/2 ml at 2100 on 2/11/2012, Cefepime 1 gram IV piggyback on 2/14/2012 at 2100, Insulin glargine 10 units on 2/15/2012 at 0900 (with notation do not hold dose without contacting physician), Cefepime 2 gram IV piggyback on 2/27/2012 at 1600 and 0400, and vancomycin 2500 mg/500 ml at 1200 and 0600 on 2/27/2012. On 3/01/2012 the medication linezolid/rtu 600 mg every 12 hours was not given on 3/1/2012 at 1600 and 0400 with no documentation present why the medication was not given. And on 3/2/2012 the medication insulin glargine 10 units at 0900 and the medication linezolid 600 mg tablet was not given.

On 9/12/2012 at approximately 10:35 am during an interview with staff AT it was stated that documentation of why the medication was held or not given should have been present in the chart.

Based on record review, interview and policy review, the facility failed to ensure that controlled substance logs for both the offsite surgical location and the in-patient surgical area are complete and accurate. Findings include:

A review of the Henry Ford health System policy no: ANES7018 subject: Controlled Substance (C/S)Distribution/Documentation implemented April 16,2012 it reads under 3. "Using an Anesthesia Kit Administration Record, each CRNA will be responsible for a daily inventory of their individual C/S box. Documentation will include: b) Administration of the C/S by the CRNA will be documented on the Anesthesia Kit Administration Record and include the patient name, quantity and substance administered, and the date and time for each C/S administered. c) All C/S waste must be co-signed by another CRNA or Anesthesiologist on the Anesthesia Kit Administration Record. d) Each C/S dispensing sheet must have the total administered, waste, and return amounts completed, with a signature of the administering CRNA prior to the narcotic box being returned to the C/S cabinet."
The policy goes on to state under 6. Each night the night pharmacist will: c. 1)"check each old kit for contents" 2) "check each dispensing sheet for completeness" 3) sign and initial each sheet after checking each kit."

During review of documents titled Henry Ford CHS; Department of Pharmacy Anesthesia Kit Administration Record for the offsite surgical area it was noted that each kit contains Fentanyl 100 mcg/2 ml (single dose vials) with 24 ml dispensed (12 vials) and Midazolam (Versed) 2 mg/2 ml with 20 mg (10 vials) dispensed. Review of documents revealed the following:

During a review of Anesthesia Kit Administration Records on 09/11/2012 for surgical dates of 08/03/2012, 08/08/2012, 08/15/2012, 08/16/2012, 08/30/2012, 09/05/2012 and 09/07/2012 it was determined that per the documentation provided, the facility was not able to account for the disposition of narcotics within the facility. The records lacked documentation in several areas for signature of administration, second signature for witness of waste and accurate or lacking count at the end of the day. The documents also contained several areas where the first entry had been changed by writing over it several times with a pen. In the signature areas the signatures were illegible or missing.

On 08/03/2012, the documentation on the Anesthesia Administration Record lacked documented waste for one (1) patient, the CRNA's signature was not legible for any of the 12 entries, single dose Fentanyl two (2) vials were divide and administered to four (4) different patients, entries on the document were altered by witting over the first entry. The documentation accounts for the administration of 22 mels of Fentanyl and 18 mg of Versed. The facility was unable to account for 2 mels of Fentanyl and 2 mg of Versed.

On 08/08/2012, the Anesthesia Kit Administration Record does not contain a legible signature for the person who administered the medications for 7 of 10 patients and does not contain a signature at all for who administered to the other three (3) patients. The documentation for kit #2 contained an area where the staff had scribbled out something and then written "error" and placed their initials.

On 08/15/2012, a review of the documentation on the Anesthesia Kit Administration Record Kit, it could not be determined how much Fentanyl or Versed was administered to patients treated on this day. The document contains six (6) areas that have been scribbled out of written over. For six (6) out of seven (7) patients there was no documented waste or inaccurately documented waste on the record. Of the patients treated, the record lacked a second staff signature for witness of waste for 5 of 7 patients. The bottom of the document was blank in the section accounting for the Versed-total administered, total waste and balance to pharmacy.

On 08/16/2012 the Anesthesia Kit Administration Record reveals that three (3) patients were treated. The documentation in the area for administration of Fentanyl contains 0's and X's where the staff had crossed out entries. The document also lacked signatures as to who administered the medications to the patients.

On 08/30/2012 the Anesthesia Kit Administration Record Kit contained six (6) areas of documentation. Four (4) of the six areas contained documentation that had been changed by witting several times over the previous entry to change the number, the second patient listed on the page had been administered Fentanyl 4 the area had then been written over several times to make it a big black 2, documentation for the fourth, fifth and sixth patient's had entries that had later been written over several times to change the documentation. None of the CRNA's signatures are legible.

On 09/05/2012 the Anesthesia Kit Administration Record lacks signatures for the administration of the medication to the five (5) patients that were administered anesthesia.

On 09/07/2012 the Anesthesia Kit Administration Record reveals that documented waste of Fentanyl after the last patient was 150 mcg (which totals 1.5 vials). The documentation lacked a second signature for the wasted narcotic or an explanation of why an entire vial plus a half vial was wasted.

During an interview/meeting with staff V, AR and AS on 09/11/2012 at 1530, staff AR and V were unable to explain the documentation problems identified. When asked to explain the documentation of the narcotics on the anesthesia kit record for 08/14/2012, staff AR could not explain what had been administered or why there was no documentation of waste. Staff AR (Department Chair of Anesthesia) stated "I have never seen this form before." Staff AR did make the comment that "the record is illegible, staff are supposed to sign their name in the section titled "signature" not just put their initials". Staff V (Director of Pharmacy) stated "We review some of these documents but not all of them." Staff V stated "this is just a document used by anesthesia" , making reference to the Anesthesia Kit Administration Record.



29955

On 9/11/2012 at approximately 1:00 PM it was revealed the documentation log of the use and waste of scheduled drugs was inaccurate according to the document "Pharmacy Anesthesia Kit Administration Record" on 8/24/2012. According to the documentation provided for 8/24/2012 the medication fentanyl 100 mcg/2 ml was dispensed as follows: 2.5 with zero waste to surgical patient #1, 2.5 with 5 of waste, and 8 with 2 of waste. The document fails to identify the quantity in either mcg or ml. During interview, staff AA it was asked how the medication is dispensed from pharmacy and if the medication is single dose or multidose vials. Staff AA responded that the vials are actually 5 ml vials and are identified as single use vials. When asked how the totals would be derived at 2.5 dispensed and 5 of waste staff, AA responded "well they are actually not used as single dose as intended because of waste".

The second document for 8/24/2012 shows fentanyl administered as follows according to surgical case: 6 with zero waste, 9 with zero waste, and 5 with zero waste. The sheet does not show units of measure (mcg or ml) and indicates that single use vials were also used for split doses between patients as confirmed by staff AA. Staff AA stated it is a common practice of the certified registered nurse anesthetists to use the 5 ml bottles to be dispensed to more than one patient.

Of the thirteen pharmacy anesthesia kit administration sheets reviewed for 8/24/2012 eight sheets showed failure to dispense medications as single dose as intended and labeled by the manufacturer. Of the six pharmacy anesthesia kit administration sheets reviewed for 8/25/2012 one sheet showed failure to dispense medications as single dose as intended and labeled by the manufacturer. Of the pharmacy anesthesia kit administration sheets reviewed for 8/26/2012 one sheet showed failure to dispense medications as single dose as intended and labeled by the manufacturer. Of the fourteen pharmacy anesthesia kit administration sheets reviewed for 8/27/2012 twelve sheets showed failure to dispense medications as single dose as intended and labeled by the manufacturer.

During an interview with staff AS, AR, and W it was asked how the sheets were monitored and kept to assure scheduled drugs were monitored and checked for any variance of what was administered, wasted, and returned to pharmacy. It was stated by staff AR that he had never seen those sheets and thought that they were a "worksheet" and not considered a formal document. Staff BW stated that if an accurate count of scheduled drugs were to be required the medical record would be ascertained in which the surgical record could be used to accurately account for medications used, wasted, and returned.

Based on record review, interview and policy review the facility failed to ensure that controlled substances could be accounted for from receipt to final disposition. Findings include:

A review of the Henry Ford Health System policy no: ANES7018 subject: Controlled Substance (C/S)Distribution/Documentation implemented April 16,2012 it reads under 3. "Using an Anesthesia Kit Administration Record, each CRNA will be responsible for a daily inventory of their individual C/S box. Documentation will include: b) Administration of the C/S by the CRNA will be documented on the Anesthesia Kit Administration Record and include the patient name, quantity and substance administered, and the date and time for each C/S administered. c) All C/S waste must be co-signed by another CRNA or Anesthesiologist on the Anesthesia Kit Administration Record. d) Each C/S dispensing sheet must have the total administered, waste, and return amounts completed, with a signature of the administering CRNA prior to the narcotic box being returned to the C/S cabinet."
The policy goes on to state under 6. Each night the night pharmacist will: c. 1)"check each old kit for contents" 2) "check each dispensing sheet for completeness" 3) sign and initial each sheet after checking each kit."

During review of Anesthesia Kit Administration Records for the outpatient facility on 09/11/2012 at 0900, it was determined that the entries for administration of Fentanyl on 08/03/2012 were inaccurate. The log states that the kit contained 24 ml (12 vials) of Fentanyl 100 mcg/2 ml. The log accounts for 12 patients receiving the medication and adds up to a total of 22 ml's being administered. The documentation states that 24 ml's were administered and none returned to pharmacy; however the pharmacist checking the box documents a return of one (1) vial of Fentanyl. The record also goes on to document 20 mg's of Versed being administered with no vials being returned to pharmacy; however the amounts administered per the documentation only total up to 18 ml's and pharmacy documents a return of one (1) vial. The document also showed that four patients were given 1 ml of Fentanyl with no documentation of waste.

The Anesthesia Kit Administration Record for 08/14/2012 contains documentation of medication administered by the anesthesiologist in ml's, mcg and mg. A consensus of RN surveyors were unable to determine by documentation what had been administered to the patients. The record does not contain documentation of waste even though it does not appear that all the patients were given a full dose of Fentanyl or Versed.

The Anesthesia Kit Administration Record for 09/07/2012, reveals that a patient received one (1) ml of Fentanyl. The document shows waste for the patient of 150 ml's (1 1/2 vials) with no documented co-signature for witness of the waste.

During an interview/meeting with staff V on 09/11/2012 at 1530, he was unable to explain the documentation problems identified. When asked about the documentation of the narcotics on the anesthesia kit records for 08/03/2012, 08/14/2012 and 09/07/2012 he stated "I did not know why the staff would have wasted an entire vial of Fentanyl, I am not sure why there was not a witness signature" and he was "not sure why there was no other documentation of waste for the other patients." Staff V (Director of Pharmacy) stated "We review some of these documents but not all of them." Staff V stated that "This is just a document used by anesthesia" , making reference to the Anesthesia Kit Administration Record.

Based on observation and interview the facility failed to ensure that outdated or otherwise unusable drugs were not available for patient use. Findings include:

During the observational tour on 9-10-12 of the Emergency Department following was observed:
Trauma #1 - One 1000 milliliter bag of 0.9 normal saline was found with tubing in place and no label of open or expired date.
Medication Room A- One bottle of Humulin N insulin that had expired 9-9-12 that was being drawn up by a nurse at the time of observation to be given to a patient. One bottle of Humulin N insulin that had no open or expiration date on the label.

On 9/10/2012 during an interview staff U confirmed the outdated and unlabeled medications were available for patient use.

During the observational tour on 9/11/2012 of the Intensive Care Unit the following was observed:
Medication Room- One bottle of Humulin N insulin that expired 8-11-12. This finding was confirmed by staff R 9/11/2012.

The facility failed to provide and maintain a safe environment for patients and staff.

This is evidenced by the Life Safety Code deficiencies identified. See A-709.

Based upon on-site observation and document review by Life Safety Code (LSC) surveyors, the facility does not comply with the applicable provisions of the Life Safety Code.

See the K-tags on the CMS-2567 dated September 12, 2012 for Life Safety Code.

Based on observation and interview the facility failed to ensure that supplies and equipment were maintained to ensure an acceptable level of safety and quality. Findings include:
During observation on 9/10/2012 the following was revealed in the Emergency Department:
1. One size 6, size 7, size 8 and size 9 endotracheal tubes were found open and placed back into the drawer with the other sterile items.
2. One size 6 and size 7 and two size 8 endotracheal tubes were found open and placed back into the drawer with the other sterile items.
3. One package of pediatric defibrillator pads had expired on 8-28-12
4. The refrigerators in medication room A and B had temperature logs that were not being completed as required per directions on the top of the log.

On 9/10/2012 during an interview with staff U the Emergency room findings were confirmed.

During observation on 9/11/12 the following was revealed in the Critical Care Unit:
1. Two Carbon Dioxide detectors for gastric tube placement verification had expired in 2/08 and 4/08
2. Six 100 count packages of Electrocardiogram electrodes that expired 2/11

On 9/11/2012 during an interview with staff Q the Critical Care findings were confirmed.


28273

During observation on 09/10/2012 at 1030 on the behavioral health unit, it was noted that the medication refrigerator contained both Flu and Pneumonia vaccines. A review of the refrigerator temperature logs for the months of June, July, August and September to the 8 th day of the month all showed documentation being completed one time per day. The document titled HF Wyandotte Hospital medication Refrigerator/Freezer Temperature Log (Celsius) reads "Document temperature twice daily (for vaccine storage)."

During an interview with staff H on 09/10/2012 at 1045, it was stated that the "refrigerator temperatures are monitored once daily." She confirmed that the refrigerator does contain vaccines and that the log states to monitor the refrigerator twice daily if vaccines are stored in it.

During observation on the 5 th floor medical/surgical unit on 09/10/2012 at 1445, it was noted that the refrigerator contained both Flu and Pneumonia vaccines. The temperature log revealed that staff were only monitoring the refrigerator temperature once daily.

During an interview with staff AT on 09/10/2012 at 1445, she confirmed that staff only "Monitor the refrigerator temperatures once a day."



29955

During a tour of the medical surgical unit on 9/11/012 at approximately 11:45 am it was revealed the wallaroos which house the medical record of the patients 3 of 5 of the wallaroo units were in need of repair. An interview with staff AU stated that she agreed the doors did not properly close to secure the patient information as expected and repairs were in need for those units that did not close completely.

Based on observation, record review and interview, the Infection Control Officer failed to ensure a sanitary environment. Findings include:

On 09/10/12 at approximately 1100 until 1150, during a tour of Unit 4, the following observations were made:

Medication Room
1) High dust on the Pyxis counter tops.
2) Debris on the floor.
3) Floors were dirty, especially in the corners.

Unit 4 hall way
l) Debris on the floor.
2) Accumulated dust on the top of the crash cart.
3) Floors were dirty, especially in the corners.
4) Black scuff marks on the walls and floors.
5) Sticky substances left on the charts, the top of the crash cart, and on the walls.


28273

During an observation of the dietary services area on 09/11/2012 at 1115 with staff AN , it was noted that in the dish room area there was a designated clean side and dirty side. Staff AN stated "There is not supposed to be any dirty dishes in the clean area." Observed sitting on the floor of the clean area side was a large dirty pan. Staff AN stated "That is not supposed to be there." Also, observed in the clean area side, was a very dirty fan with build up of black dust on the fan blades and blade guard covering the blades. Staff AN stated that "They (staff) were supposed to have taken the fan out of the area." Upon further inspection of the area, debris and a build up of dirt were noted on the floor where the fan was sitting along with carts of clean dishes. During the observation, a kitchen staff was observed taking a cart of clean dishes from the clean area to place into the storage area; the bottom shelf of the cart was noted to be dirty. When this was brought to staff AN's attention he told the staff that "the shelf on the cart needed to be cleaned."

During an observation on the 6 th floor medical surgical unit on 09/10/2012 at 1645, staff AK was observed going into room 609 to answer the patient's call light. The patient room had a sign hanging outside of the room stating "Contact Plus Precautions." Staff AK, was not observed putting on a gown or gloves when entering the room or performing hand hygiene when exiting the room. A couple of minutes later staff AK returned to room 609, entered without putting on a gown or gloves and delivered to the patient a glass of ice water. Staff AK then came out of the room without washing his hands.

During an interview with AK at 1650, when asked if he turned the patient's call light off when he answered it he stated "Yes."

During an interview with staff AJ on 09/10/2012 at 1655, when queried as to what staff are supposed to do when entering a room with a sign reading Contact Plus Precautions she stated "the staff are supposed to put on a gown and gloves before entering the room, remove them and perform hand hygiene before leaving the room."

A review of the sign hanging outside of room 609 on 9/10/2012 at approximately 1645 reads "Contact Plus Precautions All Staff, On entering the room, you must wear: Gown (upon contact with patient or environment), gloves, hand hygiene (with soap and water). Remove gown and gloves before leaving the patient environment. Hand hygiene must be performed immediately after gloves removed."


29313

During observations on 9-10-12 the following was observed in the Emergency Department:
1. Throughout the Emergency Department high dust areas were not being cleaned appropriately or frequently enough.
2. Trauma Room #2 had a full sharps container.
3. Nourishment room refrigerator was dirty with debris and the ice/water dispenser had scale build up.
4. Medication Room A had a full sharps container.
5. Medication Room B's refrigerator was dirty with debris and the freezer had large amounts of ice build up and needed defrosting.

On 9/10/2012 staff U confirmed the emergency room findings.

During observations on 9-11-12 the following was observed in the Critical Care Unit:
1. Nourishment room refrigerator was dirty with debris.
2. Throughout the unit high dusting was not being cleaned appropriately or frequently enough.

On 9/11/2012 staff Q confirmed the Critical Care Unit findings.

During observations on 9-11-12 the following was observed in the Intensive Care Unit:
1. Nourishment room freezer had a large amount of ice build up and needed to be defrosted
2. Medication room freezer had a large amount of ice build up and needed to be defrosted.
3. Throughout the unit high dusting was not being cleaned appropriately or frequently enough.
On 9/11/2012 staff Q confirmed the Intensive Care Unit findings.


29955

During a tour of the rehabilitation unit on 9/10/2012 at approximately 1:30 PM, it was revealed the drawers in the nutrition room had and accumulation of a sticky substance and residual from crackers and dust. An interview with staff AT was conducted at which time she was asked who is responsible for the maintenance and cleaning for the nutrition area and she stated housekeeping was in charge and responsible for keeping the nutrition area clean as well as the dietary department.

During a tour of the post operative area on 9/11/2012 at approximately 2:50 PM, it was revealed the refrigerator was dirty and the freezer area was encased in ice. Staff AU was questioned who is responsible for the maintenance of the refrigerator and he stated pharmacy was responsible to keep the refrigerator in repair and the defrosting of the freezer. It was then asked if the ice buildup had been identified and addressed and staff AU stated no that he thought pharmacy would be aware since they are responsible for the restocking of supplies in the refrigerator.

Based on medical record review and interview the facility failed to provide a copy of an "Important Message from Medicare" (IMM) to 5 out of 9 patients (#12,#17,#18, #36 and #40), which could potentially deprive patients of the information necessary to exercise their rights. Findings include:

On 09/10/12 at approximately 1100, during record review of patient #17's, chart it was revealed that the patient was admitted on 09/06/12 and document titled "An Important Message From Medicare About Your Right" had the patient's signature, but lacked a signature date.

On 09/10/12 at approximately 1130 during record review of patient #18's, chart it was revealed that the patient was admitted on 09/07/12 and document titled "An Important Message From Medicare About Your Right" was not signed until 09/10/12 which was past the 48 hour required time frame.

On 9/10/12 at approximately 1140 during an interview with staff L it was confirmed that patient #17 did not date the IMM, and patient #18 did not sign the IMM within the 48 hour time frame.


28273

During review of the medical record for patient #36 on 09/10/2012 at 1430, it revealed that the patient had been admitted to the 5 th floor medical/surgical unit of the hospital on 09/07/2012. The Important Message from Medicare (IMM) had not been given to the patient at the time of the record review.

During an interview with staff AT on 09/10/2012 at 1430, she confirmed the findings and stated "there should be one on the chart; they are supposed to be completed within 48 hours of admission."

During review of the medical record for patient #40 on 09/10/2012 at 1630, it revealed that the patient had been admitted to the 6 th floor medical/surgical unit on 09/07/2012. The IMM was not completed on the patient until 09/10/2012.

During an interview with staff AJ on 09/10/2012 at 1630 she confirmed the findings and stated that "the IMMs are supposed to be completed within 48 hours of the patient being admitted."



29955

On 9/10/2012 at approximately 1025 AM during review of patient # 12 it was revealed the patient did not receive the document "An Important Message from Medicare" within the 48 hours of admission to the hospital on 9/4/2012 and the medical record was absent of any documentation of the "Important Message from Medicare". An interview with staff AS confirmed the "Important Message from Medicare" was not in the patient's chart and when asked what the requirement for providing the "Important Message from Medicare" staff AS stated within 48 hours of admission.

Based on medical record review and interview the facility failed to ensure that the administration of scheduled medications were documented on the medication administration record for 2 of 14 patient's (#12 and #55) resulting in the potential for hypertension and infection. Findings include:

On 9/10/2012 at approximately 10:45 am during medical record review of patient # 12's medication administration record it was noted the medication hydralazine 25 mg was not administered to the patient as ordered at 0500 on 9/6/2012 and 9/7/2012. An order to discontinue or not dispense the medication was not found in the chart.

On 9/10/2012 at approximately 1045 during an interview with staff AT it was confirmed that the medication had not been dispensed as ordered and stated that a note should have been made if the patient had refused the medication, but at the time of review of the chart no note could be found why the medication had been missed.

On 9/12/2012 at approximately 10:35 am during the medical record review of patient #55's medication administration record it was noted the medication sucralfate suspension 10 ml was not dispensed as ordered at 1700 on 2/12/2012. Further review of the medication administration records revealed the following medications were not dispensed as ordered: Famotidine 20 mg/2 ml at 2100 on 2/11/2012, Cefepime 1 gram IV piggyback on 2/14/2012 at 2100, Insulin glargine 10 units on 2/15/2012 at 0900 (with notation do not hold dose without contacting physician), Cefepime 2 gram IV piggyback on 2/27/2012 at 1600 and 0400, and vancomycin 2500 mg/500 ml at 1200 and 0600 on 2/27/2012. On 3/01/2012 the medication linezolid/rtu 600 mg every 12 hours was not given on 3/1/2012 at 1600 and 0400 with no documentation present why the medication was not given. And on 3/2/2012 the medication insulin glargine 10 units at 0900 and the medication linezolid 600 mg tablet was not given.

On 9/12/2012 at approximately 10:35 am during an interview with staff AT it was stated that documentation of why the medication was held or not given should have been present in the chart.

Based on record review, interview and policy review, the facility failed to ensure that controlled substance logs for both the offsite surgical location and the in-patient surgical area are complete and accurate. Findings include:

A review of the Henry Ford health System policy no: ANES7018 subject: Controlled Substance (C/S)Distribution/Documentation implemented April 16,2012 it reads under 3. "Using an Anesthesia Kit Administration Record, each CRNA will be responsible for a daily inventory of their individual C/S box. Documentation will include: b) Administration of the C/S by the CRNA will be documented on the Anesthesia Kit Administration Record and include the patient name, quantity and substance administered, and the date and time for each C/S administered. c) All C/S waste must be co-signed by another CRNA or Anesthesiologist on the Anesthesia Kit Administration Record. d) Each C/S dispensing sheet must have the total administered, waste, and return amounts completed, with a signature of the administering CRNA prior to the narcotic box being returned to the C/S cabinet."
The policy goes on to state under 6. Each night the night pharmacist will: c. 1)"check each old kit for contents" 2) "check each dispensing sheet for completeness" 3) sign and initial each sheet after checking each kit."

During review of documents titled Henry Ford CHS; Department of Pharmacy Anesthesia Kit Administration Record for the offsite surgical area it was noted that each kit contains Fentanyl 100 mcg/2 ml (single dose vials) with 24 ml dispensed (12 vials) and Midazolam (Versed) 2 mg/2 ml with 20 mg (10 vials) dispensed. Review of documents revealed the following:

During a review of Anesthesia Kit Administration Records on 09/11/2012 for surgical dates of 08/03/2012, 08/08/2012, 08/15/2012, 08/16/2012, 08/30/2012, 09/05/2012 and 09/07/2012 it was determined that per the documentation provided, the facility was not able to account for the disposition of narcotics within the facility. The records lacked documentation in several areas for signature of administration, second signature for witness of waste and accurate or lacking count at the end of the day. The documents also contained several areas where the first entry had been changed by writing over it several times with a pen. In the signature areas the signatures were illegible or missing.

On 08/03/2012, the documentation on the Anesthesia Administration Record lacked documented waste for one (1) patient, the CRNA's signature was not legible for any of the 12 entries, single dose Fentanyl two (2) vials were divide and administered to four (4) different patients, entries on the document were altered by witting over the first entry. The documentation accounts for the administration of 22 mels of Fentanyl and 18 mg of Versed. The facility was unable to account for 2 mels of Fentanyl and 2 mg of Versed.

On 08/08/2012, the Anesthesia Kit Administration Record does not contain a legible signature for the person who administered the medications for 7 of 10 patients and does not contain a signature at all for who administered to the other three (3) patients. The documentation for kit #2 contained an area where the staff had scribbled out something and then written "error" and placed their initials.

On 08/15/2012, a review of the documentation on the Anesthesia Kit Administration Record Kit, it could not be determined how much Fentanyl or Versed was administered to patients treated on this day. The document contains six (6) areas that have been scribbled out of written over. For six (6) out of seven (7) patients there was no documented waste or inaccurately documented waste on the record. Of the patients treated, the record lacked a second staff signature for witness of waste for 5 of 7 patients. The bottom of the document was blank in the section accounting for the Versed-total administered, total waste and balance to pharmacy.

On 08/16/2012 the Anesthesia Kit Administration Record reveals that three (3) patients were treated. The documentation in the area for administration of Fentanyl contains 0's and X's where the staff had crossed out entries. The document also lacked signatures as to who administered the medications to the patients.

On 08/30/2012 the Anesthesia Kit Administration Record Kit contained six (6) areas of documentation. Four (4) of the six areas contained documentation that had been changed by witting several times over the previous entry to change the number, the second patient listed on the page had been administered Fentanyl 4 the area had then been written over several times to make it a big black 2, documentation for the fourth, fifth and sixth patient's had entries that had later been written over several times to change the documentation. None of the CRNA's signatures are legible.

On 09/05/2012 the Anesthesia Kit Administration Record lacks signatures for the administration of the medication to the five (5) patients that were administered anesthesia.

On 09/07/2012 the Anesthesia Kit Administration Record reveals that documented waste of Fentanyl after the last patient was 150 mcg (which totals 1.5 vials). The documentation lacked a second signature for the wasted narcotic or an explanation of why an entire vial plus a half vial was wasted.

During an interview/meeting with staff V, AR and AS on 09/11/2012 at 1530, staff AR and V were unable to explain the documentation problems identified. When asked to explain the documentation of the narcotics on the anesthesia kit record for 08/14/2012, staff AR could not explain what had been administered or why there was no documentation of waste. Staff AR (Department Chair of Anesthesia) stated "I have never seen this form before." Staff AR did make the comment that "the record is illegible, staff are supposed to sign their name in the section titled "signature" not just put their initials". Staff V (Director of Pharmacy) stated "We review some of these documents but not all of them." Staff V stated "this is just a document used by anesthesia" , making reference to the Anesthesia Kit Administration Record.



29955

On 9/11/2012 at approximately 1:00 PM it was revealed the documentation log of the use and waste of scheduled drugs was inaccurate according to the document "Pharmacy Anesthesia Kit Administration Record" on 8/24/2012. According to the documentation provided for 8/24/2012 the medication fentanyl 100 mcg/2 ml was dispensed as follows: 2.5 with zero waste to surgical patient #1, 2.5 with 5 of waste, and 8 with 2 of waste. The document fails to identify the quantity in either mcg or ml. During interview, staff AA it was asked how the medication is dispensed from pharmacy and if the medication is single dose or multidose vials. Staff AA responded that the vials are actually 5 ml vials and are identified as single use vials. When asked how the totals would be derived at 2.5 dispensed and 5 of waste staff, AA responded "well they are actually not used as single dose as intended because of waste".

The second document for 8/24/2012 shows fentanyl administered as follows according to surgical case: 6 with zero waste, 9 with zero waste, and 5 with zero waste. The sheet does not show units of measure (mcg or ml) and indicates that single use vials were also used for split doses between patients as confirmed by staff AA. Staff AA stated it is a common practice of the certified registered nurse anesthetists to use the 5 ml bottles to be dispensed to more than one patient.

Of the thirteen pharmacy anesthesia kit administration sheets reviewed for 8/24/2012 eight sheets showed failure to dispense medications as single dose as intended and labeled by the manufacturer. Of the six pharmacy anesthesia kit administration sheets reviewed for 8/25/2012 one sheet showed failure to dispense medications as single dose as intended and labeled by the manufacturer. Of the pharmacy anesthesia kit administration sheets reviewed for 8/26/2012 one sheet showed failure to dispense medications as single dose as intended and labeled by the manufacturer. Of the fourteen pharmacy anesthesia kit administration sheets reviewed for 8/27/2012 twelve sheets showed failure to dispense medications as single dose as intended and labeled by the manufacturer.

During an interview with staff AS, AR, and W it was asked how the sheets were monitored and kept to assure scheduled drugs were monitored and checked for any variance of what was administered, wasted, and returned to pharmacy. It was stated by staff AR that he had never seen those sheets and thought that they were a "worksheet" and not considered a formal document. Staff BW stated that if an accurate count of scheduled drugs were to be required the medical record would be ascertained in which the surgical record could be used to accurately account for medications used, wasted, and returned.

Based on record review, interview and policy review the facility failed to ensure that controlled substances could be accounted for from receipt to final disposition. Findings include:

A review of the Henry Ford Health System policy no: ANES7018 subject: Controlled Substance (C/S)Distribution/Documentation implemented April 16,2012 it reads under 3. "Using an Anesthesia Kit Administration Record, each CRNA will be responsible for a daily inventory of their individual C/S box. Documentation will include: b) Administration of the C/S by the CRNA will be documented on the Anesthesia Kit Administration Record and include the patient name, quantity and substance administered, and the date and time for each C/S administered. c) All C/S waste must be co-signed by another CRNA or Anesthesiologist on the Anesthesia Kit Administration Record. d) Each C/S dispensing sheet must have the total administered, waste, and return amounts completed, with a signature of the administering CRNA prior to the narcotic box being returned to the C/S cabinet."
The policy goes on to state under 6. Each night the night pharmacist will: c. 1)"check each old kit for contents" 2) "check each dispensing sheet for completeness" 3) sign and initial each sheet after checking each kit."

During review of Anesthesia Kit Administration Records for the outpatient facility on 09/11/2012 at 0900, it was determined that the entries for administration of Fentanyl on 08/03/2012 were inaccurate. The log states that the kit contained 24 ml (12 vials) of Fentanyl 100 mcg/2 ml. The log accounts for 12 patients receiving the medication and adds up to a total of 22 ml's being administered. The documentation states that 24 ml's were administered and none returned to pharmacy; however the pharmacist checking the box documents a return of one (1) vial of Fentanyl. The record also goes on to document 20 mg's of Versed being administered with no vials being returned to pharmacy; however the amounts administered per the documentation only total up to 18 ml's and pharmacy documents a return of one (1) vial. The document also showed that four patients were given 1 ml of Fentanyl with no documentation of waste.

The Anesthesia Kit Administration Record for 08/14/2012 contains documentation of medication administered by the anesthesiologist in ml's, mcg and mg. A consensus of RN surveyors were unable to determine by documentation what had been administered to the patients. The record does not contain documentation of waste even though it does not appear that all the patients were given a full dose of Fentanyl or Versed.

The Anesthesia Kit Administration Record for 09/07/2012, reveals that a patient received one (1) ml of Fentanyl. The document shows waste for the patient of 150 ml's (1 1/2 vials) with no documented co-signature for witness of the waste.

During an interview/meeting with staff V on 09/11/2012 at 1530, he was unable to explain the documentation problems identified. When asked about the documentation of the narcotics on the anesthesia kit records for 08/03/2012, 08/14/2012 and 09/07/2012 he stated "I did not know why the staff would have wasted an entire vial of Fentanyl, I am not sure why there was not a witness signature" and he was "not sure why there was no other documentation of waste for the other patients." Staff V (Director of Pharmacy) stated "We review some of these documents but not all of them." Staff V stated that "This is just a document used by anesthesia" , making reference to the Anesthesia Kit Administration Record.

Based on observation and interview the facility failed to ensure that outdated or otherwise unusable drugs were not available for patient use. Findings include:

During the observational tour on 9-10-12 of the Emergency Department following was observed:
Trauma #1 - One 1000 milliliter bag of 0.9 normal saline was found with tubing in place and no label of open or expired date.
Medication Room A- One bottle of Humulin N insulin that had expired 9-9-12 that was being drawn up by a nurse at the time of observation to be given to a patient. One bottle of Humulin N insulin that had no open or expiration date on the label.

On 9/10/2012 during an interview staff U confirmed the outdated and unlabeled medications were available for patient use.

During the observational tour on 9/11/2012 of the Intensive Care Unit the following was observed:
Medication Room- One bottle of Humulin N insulin that expired 8-11-12. This finding was confirmed by staff R 9/11/2012.

The facility failed to provide and maintain a safe environment for patients and staff.

This is evidenced by the Life Safety Code deficiencies identified. See A-709.

Based upon on-site observation and document review by Life Safety Code (LSC) surveyors, the facility does not comply with the applicable provisions of the Life Safety Code.

See the K-tags on the CMS-2567 dated September 12, 2012 for Life Safety Code.

Based on observation and interview the facility failed to ensure that supplies and equipment were maintained to ensure an acceptable level of safety and quality. Findings include:
During observation on 9/10/2012 the following was revealed in the Emergency Department:
1. One size 6, size 7, size 8 and size 9 endotracheal tubes were found open and placed back into the drawer with the other sterile items.
2. One size 6 and size 7 and two size 8 endotracheal tubes were found open and placed back into the drawer with the other sterile items.
3. One package of pediatric defibrillator pads had expired on 8-28-12
4. The refrigerators in medication room A and B had temperature logs that were not being completed as required per directions on the top of the log.

On 9/10/2012 during an interview with staff U the Emergency room findings were confirmed.

During observation on 9/11/12 the following was revealed in the Critical Care Unit:
1. Two Carbon Dioxide detectors for gastric tube placement verification had expired in 2/08 and 4/08
2. Six 100 count packages of Electrocardiogram electrodes that expired 2/11

On 9/11/2012 during an interview with staff Q the Critical Care findings were confirmed.


28273

During observation on 09/10/2012 at 1030 on the behavioral health unit, it was noted that the medication refrigerator contained both Flu and Pneumonia vaccines. A review of the refrigerator temperature logs for the months of June, July, August and September to the 8 th day of the month all showed documentation being completed one time per day. The document titled HF Wyandotte Hospital medication Refrigerator/Freezer Temperature Log (Celsius) reads "Document temperature twice daily (for vaccine storage)."

During an interview with staff H on 09/10/2012 at 1045, it was stated that the "refrigerator temperatures are monitored once daily." She confirmed that the refrigerator does contain vaccines and that the log states to monitor the refrigerator twice daily if vaccines are stored in it.

During observation on the 5 th floor medical/surgical unit on 09/10/2012 at 1445, it was noted that the refrigerator contained both Flu and Pneumonia vaccines. The temperature log revealed that staff were only monitoring the refrigerator temperature once daily.

During an interview with staff AT on 09/10/2012 at 1445, she confirmed that staff only "Monitor the refrigerator temperatures once a day."



29955

During a tour of the medical surgical unit on 9/11/012 at approximately 11:45 am it was revealed the wallaroos which house the medical record of the patients 3 of 5 of the wallaroo units were in need of repair. An interview with staff AU stated that she agreed the doors did not properly close to secure the patient information as expected and repairs were in need for those units that did not close completely.

Based on observation, record review and interview, the Infection Control Officer failed to ensure a sanitary environment. Findings include:

On 09/10/12 at approximately 1100 until 1150, during a tour of Unit 4, the following observations were made:

Medication Room
1) High dust on the Pyxis counter tops.
2) Debris on the floor.
3) Floors were dirty, especially in the corners.

Unit 4 hall way
l) Debris on the floor.
2) Accumulated dust on the top of the crash cart.
3) Floors were dirty, especially in the corners.
4) Black scuff marks on the walls and floors.
5) Sticky substances left on the charts, the top of the crash cart, and on the walls.


28273

During an observation of the dietary services area on 09/11/2012 at 1115 with staff AN , it was noted that in the dish room area there was a designated clean side and dirty side. Staff AN stated "There is not supposed to be any dirty dishes in the clean area." Observed sitting on the floor of the clean area side was a large dirty pan. Staff AN stated "That is not supposed to be there." Also, observed in the clean area side, was a very dirty fan with build up of black dust on the fan blades and blade guard covering the blades. Staff AN stated that "They (staff) were supposed to have taken the fan out of the area." Upon further inspection of the area, debris and a build up of dirt were noted on the floor where the fan was sitting along with carts of clean dishes. During the observation, a kitchen staff was observed taking a cart of clean dishes from the clean area to place into the storage area; the bottom shelf of the cart was noted to be dirty. When this was brought to staff AN's attention he told the staff that "the shelf on the cart needed to be cleaned."

During an observation on the 6 th floor medical surgical unit on 09/10/2012 at 1645, staff AK was observed going into room 609 to answer the patient's call light. The patient room had a sign hanging outside of the room stating "Contact Plus Precautions." Staff AK, was not observed putting on a gown or gloves when entering the room or performing hand hygiene when exiting the room. A couple of minutes later staff AK returned to room 609, entered without putting on a gown or gloves and delivered to the patient a glass of ice water. Staff AK then came out of the room without washing his hands.

During an interview with AK at 1650, when asked if he turned the patient's call light off when he answered it he stated "Yes."

During an interview with staff AJ on 09/10/2012 at 1655, when queried as to what staff are supposed to do when entering a room with a sign reading Contact Plus Precautions she stated "the staff are supposed to put on a gown and gloves before entering the room, remove them and perform hand hygiene before leaving the room."

A review of the sign hanging outside of room 609 on 9/10/2012 at approximately 1645 reads "Contact Plus Precautions All Staff, On entering the room, you must wear: Gown (upon contact with patient or environment), gloves, hand hygiene (with soap and water). Remove gown and gloves before leaving the patient environment. Hand hygiene must be performed immediately after gloves removed."


29313

During observations on 9-10-12 the following was observed in the Emergency Department:
1. Throughout the Emergency Department high dust areas were not being cleaned appropriately or frequently enough.
2. Trauma Room #2 had a full sharps container.
3. Nourishment room refrigerator was dirty with debris and the ice/water dispenser had scale build up.
4. Medication Room A had a full sharps container.
5. Medication Room B's refrigerator was dirty with debris and the freezer had large amounts of ice build up and needed defrosting.

On 9/10/2012 staff U confirmed the emergency room findings.

During observations on 9-11-12 the following was observed in the Critical Care Unit:
1. Nourishment room refrigerator was dirty with debris.
2. Throughout the unit high dusting was not being cleaned appropriately or frequently enough.

On 9/11/2012 staff Q confirmed the Critical Care Unit findings.

During observations on 9-11-12 the following was observed in the Intensive Care Unit:
1. Nourishment room freezer had a large amount of ice build up and needed to be defrosted
2. Medication room freezer had a large amount of ice build up and needed to be defrosted.
3. Throughout the unit high dusting was not being cleaned appropriately or frequently enough.
On 9/11/2012 staff Q confirmed the Intensive Care Unit findings.


29955

During a tour of the rehabilitation unit on 9/10/2012 at approximately 1:30 PM, it was revealed the drawers in the nutrition room had and accumulation of a sticky substance and residual from crackers and dust. An interview with staff AT was conducted at which time she was asked who is responsible for the maintenance and cleaning for the nutrition area and she stated housekeeping was in charge and responsible for keeping the nutrition area clean as well as the dietary department.

During a tour of the post operative area on 9/11/2012 at approximately 2:50 PM, it was revealed the refrigerator was dirty and the freezer area was encased in ice. Staff AU was questioned who is responsible for the maintenance of the refrigerator and he stated pharmacy was responsible to keep the refrigerator in repair and the defrosting of the freezer. It was then asked if the ice buildup had been identified and addressed and staff AU stated no that he thought pharmacy would be aware since they are responsible for the restocking of supplies in the refrigerator.