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Based on patient and facility record review and interviews with staff, the governing body failed to ensure that approved policies and procedures were implemented and being used by the facility in the Outpatient Surgery Unit to provide safe and proper care to the patients being treated.

The findings include:

1. A review of the policies and procedures in the Outpatient Surgery Unit, revealed that all admissions to the unit required admitting orders. A review of the clinical records for 15 outpatients revealed that 6 of the patients had surgical procedures performed with no admitting orders available to staff for review. Refer to A065.

2. The facility failed to ensure that all drugs and biologicals were administered and/or administered in accordance with Federal regulations, professional standards and approved medical staff policies and procedures. This failure affected 6 of 15 outpatient sampled patients, #s 6, 7, 8, 10, 11, 14 and 15 as well as patients receiving care in the cardiac catheter laboratory. Refer to A405, A406.
3. The facility failed to obtain orders to administer intravenous (IV) fluids for 2 of 15 outpatient sampled patients, #s 13 and 14. Refer to A406.
5. The facility failed to keep anesthetic medications secured. Refer to A502.
6. The facility failed to provide for the safe care and monitoring of patients by having the circulating Registered Nurse (RN) also administer moderate sedation for 4 of the 15 outpatient sampled patients, #s 7,10,11,and 14. In all 4 cases there was only one RN available to both circulate and sedate, rendering the RN unavailable to effectively respond to any possible emergency. Refer to A944.
7. The outpatient surgery departments of the facility failed to be consistent and assure the achievement of high standards of medical practice and patient care in 6 of 15 outpatient sampled patients, #s 6, 7, 8, 10, 13, and 14. Refer to A951.
In addition, the facility failed to practice acceptable standards in regards to the sterilization process of single use items. The above practices in the Outpatient Surgery Unit are in direct contradiction to the policies and procedures approved by the governing body. Refer to A951.

Based on patient and facility record reviews, and interviews with staff, the facility failed to ensure that procedures performed on patients in the outpatient surgery center, were admitted to the facility by a licensed practitioner on the medical staff at the time of admission for six of fifteen patients reviewed.

The findings include:

1. Clinical record review for Patient #6 revealed that there were no physician orders located within the clinical record that directed the nursing staff to admit the patient or indicated what surgical procedure the patient was having.
2. Clinical record review for Patient #7 revealed that there were no orders in the chart that directed the nursing staff to admit the patient or indicted what surgical procedure(s) the patient was having. 3. Clinical record review for Patient #8 revealed that there were no orders in the chart that directed the nursing staff to admit the patient or indicated what surgical procedure(s) the patient was having.
4. Clinical record review of Patient #10 revealed that there were no orders in the chart that directed the nursing staff to admit the patient or indicted what surgical procedure the patient was having.
5. Clinical record review for Patient #13 revealed that there were no physician orders located in the chart that directed the nursing staff to admit the patient or indicated what surgical procedure the patient was having.
6. Clinical record review for Patient #14 revealed that there were no physician orders located in the chart that directed the nursing staff to admit the patient or indicted what surgical procedure the patient was having.

Interviews with staff reveal that patients received surgical procedures based on the surgical schedule, without the admitting orders from a licensed physician. A review of the policies and procedures for outpatient surgery revealed the facility required admitting orders on all patients in all units within the hospital.

7. An interview with the Charge Nurse of Pre-admission Testing (PAT) on 01/31/2011 at approximately 11:30am revealed that they perform prescribed testing on patients who are scheduled to have outpatient surgery. She stated that they receive the patient information directly from the admitting physician's office or clinic. The form that the admitting physician sends to them is called a Request for Elective Hospital Services. It notes the patient demographic information, the insurance information, the procedure information and has a section for PAT orders. The physician is to indicate the type of admission, length of stay, blood work and any testing he or she may require. The form is signed, dated and timed. This form is sent via a PAT packet to the outpatient surgery clinic and includes all PAT testing that was completed prior. She stated that patients who are admitted directly from the physician's office or clinic do not come to PAT and therefore no PAT packet is created for that patient.
8.Interview with the GI lab ( gastrointestinal laboratory) nurse manager on 02/01/2011 at approximately 10:35am revealed that PAT puts together a package for the outpatient surgical clinic that contains any pre-admission test such as blood laboratories or EKGs (electrocardiograms). She stated that if the physician included orders they would also be sent with the PAT package. She stated that the orders are written directly on the Request for Elective Hospital Services form in the box that states "procedure information" and "PAT orders". She stated that the physicians do not write admitting orders on a physician ' s order sheet, only orders to start IV's ( intravenous line), access porta catheters, check blood sugars and have patient sign procedure consent form. She stated that the nursing staff looks at the daily schedule in order to know what procedure the patient will be having. This interview was conducted in front of the director of Nursing for outpatient surgery, the director of peri-operative services, a pre-operative/post operative nurse who works full time in the outpatient surgery clinic and other upper management staff. The peri-operative nurse concurred, stating that depending on if the patient has been seen in PAT or not, depended on whether they received a PAT packet containing the Request form. She further stated that if the patient was a same day admission and did not go through PAT , they may or may not bring with them orders given to them by the physician. She agreed that she would know what procedure the patient was to have based on the schedule that is sent daily from admitting and/or that the patient themselves could tell her. In addition, she stated that sometimes the patients will bring their consent forms with them, which also states what procedure the patient is to have. No one present expressed concerns with the above process.
9. An interview with a peri-operative nurse from the outpatient surgery clinic on 02/04/11 at approximately 12 noon confirmed that if a patient is seen by PAT that they will receive a PAT packet that might contain the Request for Elective Hospital Services but does not always contain that form. She stated that the Request form served as the admitting order. She also confirmed that if a patient was a same day admission and not seen by PAT, the outpatient surgery clinic did not usually receive the Request form. She stated that when the physician arrived after the patient was admitted, he/she would sometimes bring orders in or verbally give those orders. She stated that she never felt the need to write verbal admitting orders. In addition, the peri-operative nurse stated that if the Request form was not in the clinical record it did not stop the patient from being admitted and she would not go looking in other departments for that form. She stated that she did not know if admitting or PAT kept the Request forms sometimes and it wasn' t something that she commonly looked for in the clinical record. She stated that she knew to admit the patient by virtue of them being on the schedule.
10. A review of the facility's policy and procedure on medical orders revealed that all patients admitted to the facility must have admitting orders. Departments performing testing procedures for outpatient purposes are required to maintain copies of all outpatient orders. All orders are to be written on the physician's order sheet and are to be dated, timed and signed.
The lack of admitting orders, available to staff to perform procedures in the outpatient surgery places patients at risk for adverse incidents due to staff's inability to confirm the admitting physician, the specific order for the procedure to be performed and the inability to review these with the patients prior to surgery.

Based on review of the facility QA/PI (Quality Assessment Performance) documentation and interview with the quality assurance manager, the facility failed to develop quality indicators to ensure the improvement of health outcomes specific to the outpatient surgery department..

The findings include:

A review of the facility QA/PI did not reveal any activities to ensure that patient admissions had physician orders to admit the patient and what surgical procedure the patient was to have for 6 of the 15 patients whose charts were reviewed.
Examples of these are listed below;

1. Clinical record review for Patient #6 revealed that there were no physician orders located within the clinical record that directed the nursing staff to admit the patient or indicated what surgical procedure the patient was having.
2. Clinical record review for Patient #7 revealed that there were no orders in the chart that directed the nursing staff to admit the patient or indicted what surgical procedure(s) the patient was having.
3. Clinical record review for Patient #8 revealed that there were no orders in the chart that directed the nursing staff to admit the patient or indicated what surgical procedure(s) the patient was having.
4. Clinical record review of Patient #10 revealed that there were no orders in the chart that directed the nursing staff to admit the patient or indicated what surgical procedure the patient was having.
5. Clinical record review for Patient #13 revealed that there were no physician orders located in the chart that directed the nursing staff to admit the patient or indicated what surgical procedure the patient was having.
6. Clinical record review for Patient #14 revealed that there were no physician orders located in the chart that directed the nursing staff to admit the patient or indicated what surgical procedure the patient was having.

7. Interviews with staff reveal that patients received surgical procedures based on the surgical schedule, without the admitting orders from a licensed physician. A review of the policies and procedures for outpatient surgery revealed the facility required admitting orders on all patients in all units within the hospital.

8. An interview with the Charge Nurse of Pre-admission Testing (PAT) on 01/31/2011 at approximately 11:30am revealed that they perform prescribed testing on patients who are scheduled to have outpatient surgery. She stated that they receive the patient information directly from the admitting physician's office or clinic. The form that the admitting physician sends to them is called a Request for Elective Hospital Services. It notes the patient demographic information, the insurance information, the procedure information and has a section for PAT orders. The physician is to indicate the type of admission, length of stay, blood work and any testing he or she may require. The form is signed, dated and timed. This form is sent via a PAT packet to the outpatient surgery clinic and includes all PAT testing that was completed prior. She stated that patients who are admitted directly from the physician's office or clinic do not come to PAT and therefore no PAT packet is created for that patient.
9. Interview with the GI lab ( gastrointestinal laboratory) nurse manager on 02/01/2011 at approximately 10:35am revealed that PAT puts together a package for the outpatient surgical clinic that contains any pre-admission test such as blood laboratories or EKGs (electrocardiograms). She stated that if the physician included orders they would also be sent with the PAT package. She stated that the orders are written directly on the Request for Elective Hospital Services form in the box that states "procedure information" and "PAT orders". She stated that the physicians do not write admitting orders on a physician's order sheet, only orders to start IV's ( intravenous line), access porta catheters, check blood sugars and have patient sign procedure consent form. She stated that the nursing staff looks at the daily schedule in order to know what procedure the patient will be having. This interview was conducted in front of the director of Nursing for outpatient surgery, the director of peri-operative services, a pre-operative/post operative nurse who works full time in the outpatient surgery clinic and other upper management staff. The peri-operative nurse concurred, stating that depending on if the patient has been seen in PAT or not, depended on whether they received a PAT packet containing the Request form. She further stated that if the patient was a same day admission and did not go through PAT , they may or may not bring with them orders given to them by the physician. She agreed that she would know what procedure the patient was to have based on the schedule that is sent daily from admitting and/or that the patient themselves could tell her. In addition, she stated that sometimes the patients will bring their consent forms with them, which also states what procedure the patient is to have. No one present expressed concerns with the above process.
10. An interview with a peri-operative nurse from the outpatient surgery clinic on 02/04/11 at approximately 12 noon confirmed that if a patient is seen by PAT that they will receive a PAT packet that might contain the Request for Elective Hospital Services but does not always contain that form. She stated that the Request form served as the admitting order. She also confirmed that if a patient was a same day admission and not seen by PAT, the outpatient surgery clinic did not usually receive the Request form. She stated that when the physician arrived after the patient was admitted, he/she would sometimes bring orders in or verbally give those orders. She stated that she never felt the need to write verbal admitting orders. In addition, the peri-operative nurse stated that if the Request form was not in the clinical record it did not stop the patient from being admitted and she would not go looking in other departments for that form. She stated that she did not know if admitting or PAT kept the Request forms sometimes and it wasn't something that she commonly looked for in the clinical record. She stated that she knew to admit the patient by virtue of them being on the schedule.
11. A review of the facility's policy and procedure on medical orders revealed that all patients admitted to the facility must have admitting orders. Departments performing testing procedures for outpatient purposes are required to maintain copies of all outpatient orders. All orders are to be written on the physician's order sheet and are to be dated, timed and signed.
The lack of admitting orders, available to staff to perform procedures in the outpatient surgery places patients at risk for adverse incidents due to staff's inability to confirm the admitting physician, the specific order for the procedure to be performed and the inability to review these with the patients prior to surgery.

Based on clinical record review, observation, staff interview and policy review, the facility failed to ensure that all drugs and biologicals were administered and/or administered in accordance with Federal regulations, professional standards and approved medical staff policies and procedures. This failure affected 6 of 15 outpatient sampled patients, #s 6, 7, 8, 10, 11, 14 and 15 and included patients receiving care in the cardiac catheter laboratory.


The findings include

1. During tour of the Cardiac Catheter Lab on 1/31/2011 at 1:15 pm , it was discovered that the nurses regularly mix cardiac medications prior to administration in the unit (including but not limited to Platelet glycoprotein IIb/IIIa receptor antagonists, Class III antiarrythmic agents, Fibrin selective fibrolytic agents, class III antiarrythmic agents, calcium channel blockers, and short acting beta blockers).

The nurse manager of the cardiac catheter lab was interviewed on 2/1/11 at 8:00 am regarding the nurses admixing medications. Per the nurse manager, all medications given in the cardiac catheter lab are time sensitive and specific to the procedure being performed. It is typical practice for one nurse to admix medications, and then administer the medication.

The facility policy on the Administration of Intravenous Therapy was reviewed on 2/1/11 at 9:30 am. Per the policy, all medications administered by the intravenous infusion method will be prepared by the pharmacy with the exception of emergency situations in which the administration of the medication is time sensitive and a delay would result in an adverse patient outcome. In these situations, the nurse may prepare the infusion. The infusion would be verified for accuracy and co-signed on the MAR by another nurse (one of whom must be an RN).

The Patient Safety Officer and the Director of Professional Practice were interviewed on 2/2/11 at 10:20 am regarding the practice of one nurse admixing high risk medications. Both agreed it was facility policy for two nurses to check for accuracy in drug calculations when admixing cardiac high-risk medications, that this was a patient safety issue and needed to be addressed.




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2. Clinical record review for Patient # 6 revealed that she had an outpatient procedure on 02/01/11 in the gastrointestinal laboratory (GI lab). There were orders on her chart that were appropriately signed and dated by the prescribing physician and noted by a pre-operative RN. The orders included to have an intravenous (IV) with normal saline solution (NSS) started and maintained at a keep vein open (KVO) drip rate. Review of the Procedure Record maintained by the circulating operating room (OR) nurse revealed that she received the patient from pre-op with an IV of Lactated Ringers (LR) and not NSS. The IV of LR was noted to have been started pre-procedure in the right hand. Review of the Anesthesia Record revealed that at 7:56am an IV was started by the pre-op RN using a 22 gauge catheter and a 1000 ml bag of LR for IV maintenance. Extensive review of the clinical record revealed that there were no further orders, additional orders or any other indications that the order for NSS had been changed to LR. In addition, there were no nursing notes, anesthesia notes, physician notes or other entries that indicated any reason for not administering the ordered IV fluid (IVF) of NSS.
3. Clinical record review for Patient #7 revealed that she had an outpatient procedure on 02/01/11 in the GI lab. There were orders on her chart that were appropriately signed and dated by the prescribing physician and noted by a pre-operative RN. The orders included to have an IV with NSS started and maintained at a KVO drip rate. Review of the Procedure Record maintained by the circulating OR nurse revealed that she received the patient from pre-op with an IV of LR. The IV of LR was noted to have been started pre-procedure in the right hand. Review of the Moderate Sedation Record revealed that the patient's IVF was LR. Extensive review of the clinical record revealed that there were no further orders, additional orders or any other indications that the order for NSS had been changed to LR. In addition, there were no nursing notes, sedation notes, physician notes or other entries within the clinical record that indicated any reason for not administering the ordered IVF of NSS and directing the RN to administer LR in its place.
4. Clinical record review for Patient #10 revealed that she had an outpatient procedure on 02/01/11 in the GI lab. There were orders on her chart appropriately signed and dated by the prescribing physician and noted by a pre-operative RN. The orders included an order to give the patient "Labetalol 10mg IV once now then recheck blood pressure". The Labetalol order did not have the time that it was written and had only the signature of the prescribing physician. The pre-operative nurse acknowledged the order by signing her name but did not include the time of that acknowledgement. Beside the prescribing physician's signature was the word "given" but no indication as to who wrote "given" or at what time it had been written. Review of the Pre-Procedure Nursing Care and Assessment form revealed that the IVF was 1000 mls (milliliters) of LR. The section that listed "pre-op med" was blank. There was no documentation on the pre-op form that indicated Labetalol was given in pre-op. The blood pressure (BP) was recorded to be 213/85 at 7:31am and the nurse noted that she used the blue medium cuff. At 7:59am the BP was recorded at 203/86. No further BPs were recorded on the pre-op notes. There was a narrative note timed at 7:50am that recorded the physician was "here checking pt wanted BP rechecked" . The narrative note did not make any reference to the ordered Labetalol and only stated at 8:21am that a new order was noted but not stating what that order was.

Review of the Procedure Record stated that the pt arrived in the OR at 8:49am with the BP at 151/62 but did not indicate the patient was given the Labetalol in OR either. The orders also included to have an IV with NSS started and maintained at a KVO drip rate. Continued review of the Procedure Record revealed that the RN circulator received the patient from pre-op with an IV of LR. The IV of LR was noted to have been started pre-procedure in the right arm. Review of the Moderate Sedation Record revealed that the patient's IVF was LR and that no Labetalol was given by the sedation nurse either. Extensive review of the clinical record revealed that there were no further orders, additional orders or any other indications that the order for NSS had been changed to LR. In addition, there were no nursing notes, sedation notes, physician notes or other entries within the clinical record found that indicated there were any reasons for not administering the ordered Labetalol or IVF of NSS.
5. Clinical record review for Patient #11 revealed that she had an outpatient procedure on 01/31/11 in the GI lab. The orders on her chart were appropriately signed and dated by the prescribing physician and noted by a pre-operative RN. The orders included to have an IV of NSS started and maintained at a KVO drip rate. Review of the Procedure Record maintained by the circulating OR nurse revealed that she received the patient from pre-op with an IV of LR. The IV of LR was noted to have been started pre-procedure in the left hand. Review of the Moderate Sedation Record revealed that the patient's IVF was LR. Extensive review of the clinical record revealed that there were no additional orders or any other indications that the initial order for NSS had been changed to LR. In addition, there were no nursing notes, sedation notes, physician notes or other entries within the clinical record that indicated any reason for not administering the ordered IVF of NSS and directing the RN to administer LR in its place.
6. Clinical record review for Patient #14 revealed that there was an order dated and timed 1/27/11 at 11:10am stating "may give Lidocaine 4% as neb(ulizer) treatment" and underneath was written "RBTO Dr.Curry" with an illegible nurse's signature. The same nurse noted the entry on 01/27/11 at 11:11am. Above the order were the words "given @ 1115" with no name or signature associated with it. Complete record review revealed that there was no documentation found that substantiated the nurse gave the nebulizer treatment aside from the "given" note above the order.
7. Observation of Patients #7, 10 and 15 on 02/01/2011 at approximately 9:30am, while they were in the phase II recovery room, revealed that they all had IVFs being administered at the time of observation. The bags were 500mls of LR solution per the manufactures label stamped permanently on them. All IV bags had a paper sticker placed on the bags that said "NS 500 ml 2/1/11 @0645" with illegible initials beside the writing. There were 3 additional 500ml bags of LR hanging on an IV pole beside the crash cart that had the same sticker with the same nurse's initials.
8. In an interview with a peri-operative nurse on 02/01/1 at 9:35am it was revealed that she was the nurse who placed the labels, as mentioned above, on the LR IV bags. She stated it was her initials on the label. She immediately started to peel the labels off. She stated that she did not know why she placed the labels on the bags and admitted it was a mistake. She said that she normally does not label IVFs unless she was to add something, such as a medication, to the bag. She expressed her anxiety at surveyors being in the building and thought she was supposed to have all medications labeled so she placed labels on them. She had not realized that she labeled the LR with NS labels. She stated that she had not added any other medications or solutions to the LR bags. She stated that she did it when she first came on duty in the morning and that she had never done that before and it was not a common practice for her or the other nursing personnel to do this. It was shown to her that Patients #7, #10, and #15 were observed to have the mislabeled IVFs and she concurred with the findings. In addition, the facility's escorts that accompanied this surveyor to the outpatient surgery clinic and GI lab were also shown the IVFs that were hanging on the pole and the IVFs that were being administered to the patients. The escorts included, the Director of Nursing of the outpatient surgery clinics, the laboratory manager, the nurse manager, and the Administrator resident.
9. An interview with the outpatient surgery director on 02/01/11 at 0950 revealed that it is policy that a nurse documents medications he/she gives. The documentation needs to include name of medication, dose and route along with the name/signature of the person who administered it. If appropriate a response to the medication should also be recorded. She also agreed it was not a common practice for nurses to label IVFs if the contents have not been altered. She agreed that the patients mentioned above had orders for NSS and instead were given LR. She was made aware of the missed or poorly documented medication administrations.

Based on clinical record reviews, staff interviews and facility policy review, the facility failed to obtain orders to administer intravenous (IV) fluids for 2 of 16 outpatient sampled patients, #s 13 and 14.
The findings include:
1. Review of Patient (pt) #13's clinical record revealed she was in the hospital for a same day elective planned procedure on 01/24/2011. The pre-operative Registered Nurse (RN) started an IV with a 22 gauge IV catheter placed in the patient's wrist on 01/24/11 at 1:20pm. The IV solution used for the continuous infusion was documented by the same RN as being Normal Saline (NSS). The patient received the same IV fluids (IVFs) during her entire admission to the outpatient surgery center. Further review of the clinical record revealed that there were no orders found for the RN to start the IV or for the administration of maintenance fluids. There was no documentation that any attempt to obtain orders from the medical staff was made.
2. Review of Patient #14's clinical record revealed she was in the hospital for a same day elective planned procedure on 01/27/2011. The pre-operative RN started an IV with a 22 gauge IV catheter placed in the patient's hand on 01/27/11 at 0900. The IV solution used for the continuous infusion was documented by the same RN as being Lactated Ringers solution (LR). The patient received the same IVFs during her entire admission in the outpatient surgery center. Further review revealed that there were no orders found within the clinical record for the RN to start the IV or for the administration of maintenance fluids. There was no documentation that any attempt to obtain orders from the medical staff was made.
3. An interview with a peri-operative nurse on 02/01/11 at approximately 10:00am revealed that she was in agreement with the above information and added that it had never occurred to her write a verbal order when the physician or anesthesiologist told her to start an IV and what fluids to use.
4. An interview with 2nd peri-operative nurse on 02/01/11 at approximately 11:00am revealed that "often" patients are admitted without orders for IV and IVFs. She stated that frequently the physician, anesthesiologist, fellow or the Certified Nurse Anesthetist (CRNA) will order the IV from the bedside. She stated that she does not write those bedside orders as verbal orders in the clinical record. She further stated that she did not believe she needed orders to administer IVFs as it was not a medication to her and was just standard to start an IV when a patient was admitted for a procedure. She felt that starting an IV and hanging fluids was a standard protocol for outpatient surgery. When asked how she knew what specific fluids to administer (hang), she stated she just knew what the physicians liked so that is what she gave. She was unable to locate any written outpatient protocols on the administration of IVFs.
5. An interview with the lead Risk Manager (RM) Designee and a second RM designee on 02/02/11 at approximately 12:00 noon revealed they both had reviewed Patient #13 and Patient #14's clinical records and were also unable to locate any orders for starting IVs or administering IVFs. They were unable to determine if the IVF given was in agreement with the physician's plan of care.
6. Review of the facility's policy on medication administration revealed that no medication can be administered without an appropriate order from a medical staff member approved to place the order.

Based on observation and staff interviews, the facility failed to keep anesthetic medications secured.
The findings include:
1. Observation of operating room (OR) #3 on 02/01/11 at 9:10am revealed that the room was being used for storage of various items such as packaged supplies, dressing cart, unused bovies and other miscellaneous surgical equipment and supplies. OR #3 also contained a cart with 5 anesthesia medication trays sitting directly on top and out in the open. These trays were noted to contain medications that were used for general anesthesia and emergency care. The OR (#3) is an unlocked room and assessable to any staff member both licensed and unlicensed. During the unscheduled observation of OR #3 a surgical technologist (ST) walked in to gather supplies for a procedure in another OR suite. She was asked on the spot if she had seen medication trays in the room on other days and she stated yes.
2. Interview with the pharmacy technician for the outpatient surgery clinic on 02/01/11 at 9:20am revealed that there is a locked medication room which only pharmacy and licensed staff have access to. She stated that she normally keeps the anesthesia medication trays in the locked cabinet located within the locked medication room; however, she stated that today she had a problem with the door to the locked room being difficult to open and she had decided to place the trays where she could get to them more efficiently. She claimed that it was the only time she had ever not locked up the medications.
3. Interview with the facility's pharmacist on 02/02/11 at approximately 10:15am revealed that it is the policy of the facility to keep all medications secured and locked where only authorized persons may gain access. He stated that the policy applied to the anesthesia trays as well.

Based on clinical record reviews, staff interviews and facility policy review, the facility failed to provide for the safe care and monitoring of patients by having the circulating Registered Nurse (RN) also administer moderate sedation for 4 of the 15 outpatient sampled patients, #s 7,10,11,and 14. In all 4 cases there was only one RN available to both circulate and sedate, rendering the RN unavailable to effectively respond to any possible emergency.
The findings include:
1. Clinical record review for Patient (pt) #7 revealed that she had two endoscopic procedures performed on 02/01/11 in the GI lab (gastrointestinal laboratory), part of the outpatient clinic. She was given moderate sedation during the procedure. Continued clinical record review revealed that the same RN who administered the sedation was the only RN in the procedure room and was also engaged as the circulating nurse at the same time. As the circulator, she was also responsible to monitoring the only scrub technician (ST) in the OR (operating room).
2. Clinical record review for Patient #10 revealed that she had an endoscopic procedure performed on 02/01/11 in the GI lab, part of the outpatient clinic. She was given moderate sedation during the procedure. Continued clinical record review revealed that the same RN who administered the sedation was the only RN in the procedure room and was also engaged as the circulating nurse at the same time. As the circulator, she was also responsible to monitoring the only ST in the OR.
3. Clinical record review for Patient #11 revealed that she had an endoscopic procedure performed on 01/31/11 in the GI lab, part of the outpatient clinic. She was given moderate sedation during the procedure. Continued clinical record review revealed that the same RN who administered the sedation was the only RN in the procedure room and was also engaged as the circulating nurse at the same time. As the circulator, she was also responsible to monitoring the only GI technician in the OR.
4. Clinical record review for Patient #14 revealed that she had a bronchoscopy performed on 01/27/11 in the outpatient surgery clinic. She was given deep sedation during the procedure. Continued clinical record review revealed that the same RN who administered the sedation was the only RN in the procedure room and was also engaged as the circulating nurse. As the circulator, she was also responsible to monitoring the only ST in the OR.
5. An interview with the GI lab charge nurse on 02/01/11 at 10:35am revealed that it is the practice of the GI lab to have the same RN who administers sedation for a GI procedure to also circulate at the same time. She stated that it would be rare to have more than 3 people in the procedure room during a procedure. Those 3 would be the physician performing the procedure, the GI tech that assists the physician and the RN who gives the sedation medications and circulates dually. She believed this to be within policy and procedure of the hospital.
6. An interview with the Director of Outpatient surgery on 02/01/11 at 10:45am revealed that she was aware of the above mentioned practice and she concurred in that it was common place in both the GI lab and outpatient surgery. She expressed no concerns with the practice but assured that it would cease until further review was conducted by the facility.
7. Interview with the RM on 02/01/11 at 3:25pm revealed that she was surprised and concerned by the above mentioned practices. She stated that it is the policy of the facility to have one nurse dedicated to administering and monitoring sedation and to have another RN circulate. She stated that she was not aware of the above practice until told of by this surveyor.
8. Review of the hospital's policy and procedure (P&P) on moderate sedation revealed that two (2) individuals, in addition to the practitioner performing the procedure, will be available. There will be a dedicated RN assigned to continuously monitor the patient and is to have no other responsibilities other than the monitoring of the patient and administration of medications. The second person functions as a circulator and is not required to be an RN. This policy goes on to note that state regulations require that the circulator be an RN. Under the procedure portion of the P&P, in bold print, the above is restated.
9. Review of the Moderate Sedation Training Plan revealed that the above policy is incorporated into the training and all RNs that give sedation are required to complete the training.

Based on clinical record review, staff interviews, observation and facility policy and procedure review, the outpatient surgery departments of the facility failed to be consistent and assure the achievement of high standards of medical practice and patient care in 6 of 15 outpatient sampled patients, #'s 6, 7, 8, 10, 13, and 14. In addition, the facility failed to practice acceptable standards in regards to the sterilization process of single use items.
The findings include:
1. Clinical record review for Patient #6 revealed that there were no physician orders located within the clinical record that directed the nursing staff to admit the patient or indicated what surgical procedure the patient was having. Further review of the clinical record revealed that the "time out" documented on the Invasive Procedure Checklist was timed at 8:06am on the same day as surgery. The anesthesiologist was not documented as being present during that time out. The anesthesiologist documented his time out at 8:12am in his record. The procedure was documented on both the Procedure Record form and the Anesthesia Record as starting at 8:20am. There were no other documented time outs found in the clinical record to indicate a time out was performed that included all surgical team members and that it was performed immediately prior to the procedure.
2. Clinical record review for Patient #7 revealed that there were no orders in the chart that directed the nursing staff to admit the patient or indicted what surgical procedure(s) the patient was having. Continued review of the clinical record revealed that the patient had two procedures performed, one right after the other. There was an appropriately documented time out recorded on the Invasive Procedure checklist timed at 8:18am. The first procedure was documented as beginning at 8:22am. The second procedure was documented as beginning at 8:28am. There was no time out documented for the second procedure.
3. Clinical record review for Patient #8 revealed that there were no orders in the chart that directed the nursing staff to admit the patient or indicated what surgical procedure(s) the patient was having.
4. Clinical record review of Patient #10 revealed that there were no orders in the chart that directed the nursing staff to admit the patient or indicted what surgical procedure the patient was having. Continued review of the clinical record revealed that the time out was documented on the Invasive Procedure Checklist was timed at 9:20am. The procedure was documented on the Procedure Record as beginning at 0905.
5. Clinical record review for Patient #13 revealed that there were no physician orders located in the chart that directed the nursing staff to admit the patient or indicated what surgical procedure the patient was having.
6. Clinical record review for Patient #14 revealed that there were no physician orders located in the chart that directed the nursing staff to admit the patient or indicted what surgical procedure the patient was having. Continued review of the clinical record revealed that this patient received sedation given by an RN. The administration of medications used to produce sedation began at 9:48am and lasted through 10:31am. At 10:05am, the patient was recorded on the Moderate Sedation Record as having a Sedation Level of "3" . The 3rd level is defined on the record as "Responds to repeated or painful stimulation" and matches the definition of Deep Sedation in the policy and procedure as noted below during the policy and procedure review. The patient maintained a sedation level at "3" from 10:05am through 1045. It was noted that the patient was given a total of 11mg (milligrams) of Versed and 275mcg (micrograms) of Fentanyl during the course of the entire procedure. Most important to note, is that the patient received 6mg of Versed and 150mcg of Fentanyl from 10:11am through 10:31am which was after the patient was recorded as being in the deep sedated state at the level of "3".
7. Interview with the Charge Nurse of Pre-admission Testing (PAT) on 01/31/2011 at approximately 11:30am revealed that they perform prescribed testing on patients who are scheduled to have outpatient surgery. She stated that they receive the patient information directly from the admitting physician's office or clinic. The form that the admitting physician sends to them is called a Request for Elective Hospital Services. It notes the patient demographic information, the insurance information, the procedure information and has a section for PAT orders. The physician is to indicate the type of admission, length of stay, blood work and any testing he or she may require. The form is signed, dated and timed. This form is sent via a PAT packet to the outpatient surgery clinic and includes all PAT testing that was completed prior. She stated that patients who are admitted directly from the physician's office or clinic do not come to PAT and therefore no PAT packet is created for that patient.
8. Interview with the GI lab ( gastrointestinal laboratory) nurse manager on 02/01/2011 at approximately 10:35am revealed that PAT puts together a package for the outpatient surgical clinic that contains any pre-admission test such as blood laboratories or EKGs (electrocardiograms). She stated that if the physician included orders they would also be sent with the PAT package. She stated that the orders are written directly on the Request for Elective Hospital Services form in the box that states "procedure information" and "PAT orders". She stated that the physicians do not write admitting orders on a physician ' s order sheet, only orders to start IV's ( intravenous line), access porta catheters, check blood sugars and have patient sign procedure consent form. She stated that the nursing staff looks at the daily schedule in order to know what procedure the patient will be having. This interview was conducted in front of the director of Nursing for outpatient surgery, the director of peri-operative services, a pre-operative/post operative nurse who works full time in the outpatient surgery clinic and other upper management staff. The peri-operative nurse concurred, stating that depending on if the patient has been seen in PAT or not, depended on whether they received a PAT packet containing the Request form. She further stated that if the patient was a same day admission and did not go through PAT , they may or may not bring with them orders given to them by the physician. She agreed that she would know what procedure the patient was to have based on the schedule that is sent daily from admitting and/or that the patient themselves could tell her. In addition, she stated that sometimes the patients will bring their consent forms with them, which also states what procedure the patient is to have. No one present expressed concerns with the above process.
9. An interview with a peri-operative nurse from the outpatient surgery clinic on 02/04/11 at approximately 12 noon confirmed that if a patient is seen by PAT that they will receive a PAT packet that might contain the Request for Elective Hospital Services but does not always contain that form. She stated that the Request form served as the admitting order. She also confirmed that if a patient was a same day admission and not seen by PAT, the outpatient surgery clinic did not usually receive the Request form. She stated that when the physician arrived after the patient was admitted, he/she would sometimes bring orders in or verbally give those orders. She stated that she never felt the need to write verbal admitting orders. In addition, the peri-operative nurse stated that if the Request form was not in the clinical record it did not stop the patient from being admitted and she would not go looking in other departments for that form. She stated that she did not know if admitting or PAT kept the Request forms sometimes and it wasn't something that she commonly looked for in the clinical record. She stated that she knew to admit the patient by virtue of them being on the schedule.
10. Review of the facility's policy and procedure on the "time out" process requires that the time out be performed immediately prior to the start of the procedure and that all team members participate at the same time. A designated team member is to assure and document the presence of those team members. If two or more procedures are performed on the same patient, a time out is to be performed prior to each subsequent procedure and documented.
11. Review of the facility's policy and procedure on RN Moderate Sedation revealed that moderate sedation, level "2" , is defined as "a drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. "Deep sedation, level "3" is defined as "a drug induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation". As the RN participating in the moderate sedation procedure, it is the RN's responsibility to monitor and assure that the patient does not progress to a state of deep sedation. If that were to occur, the RN must cease administration of sedation. The RN may resume the administration of sedation only after the patient has recovered to a state of moderate sedation.
12. Review of AORN's (Association of peri-operative Registered Nurses) recommendation practices for RN moderate sedation that was developed by the AORN Recommended Practices Committee revealed that moderate sedation is within the scope of practice for appropriately trained RNs. The use of deep sedation is not within the scope of practice for RNs.
13. Review of the facility's policy and procedure on medical orders revealed that all patients admitted to the facility must have admitting orders. Departments performing testing procedures for outpatient purposes are required to maintain copies of all outpatient orders. All orders are to be written on the physician's order sheet and are to be dated, timed and signed.
14. An interview with the facility's lead Risk Manager Designee (RMD) on 02/03/11 at approximately 11:35am revealed she too was unable to locate admitting orders for the above mentioned patients. She and another RMD reviewed the clinical records of the above mentioned patients and were unable to locate admitting orders. They were able to locate patient #s 6, 7, 8, 10 and 14's Request for Hospital Services form under the admitting tab and both stated that the Request form would not have been assessable to the admitting nurses in outpatient surgery. In addition, they both confirmed that if the Request form served as the admitting orders, then the forms for patient's 6, 7 and 14 were blank in the box that is labeled "PAT orders" that gives the physician the option to check "admit type" such as ambulatory or inpatient.
15. An interview with the RM on 02/04/11 at approximately 11:30am revealed that she was unable to locate admitting orders for Patient #13 to include the Request for Elective Hospital Services form. She was able to locate the request forms for Patients #6, 7, 8, 10, and 14. She admitted that she did not find the Request forms in the clinical record but rather in the Admitting department's records. She felt that these Request forms would have been assessable to the pre-operative nurses. She was unable to explain how Patient's 6, 7 and 14 were admitted without the PAT admitting portion of the Request forms blank or how Patient #14 was admitted without any apparent orders.
16. Observation of multiple seal packs containing approximately 10-15 cotton tipped applicators was made during a tour of the Ophthalmology Surgery Clinic (OPS) on 02/01/11. The seal packs appeared to be sterilized and packaged on site by the ophthalmology sterile processing staff, as they were dated and initialed with a marker. The dates ranged from 06/10 to 11/10.
17. Interview with the OPS charge nurse on 02/01/11 at approximately 2:00pm revealed that the cotton tipped applicators are used during eye surgery cases. She confirmed that the applicators in the seal packs were sterilized onsite. She was able to produce an original sample of the applicators just as they were received from the manufacturers. The applicators came in a sealed sterile package with 2 inside. The package stated "Sterile, For single use only". When asked why the OPS would open the applicators, gather 10-15 each together and resterilize them in one single seal pack, she was unable to provide an answer. She offered the reason that perhaps it was easier, during a procedure, to have them all together than to have to open 5-6 separate packages. She agreed that if a package was marked single use, that it was inappropriate to resterilize. She was unclear if the applicators went through full steam sterilization or were flashed sterilized.
18. An interview with the sterilization technician (ST) for the OPS on 02/01/11 at 1:30pm revealed he was not familiar with the practice as mentioned above and could not provide any answers. He stated that he had never used a seal pack during any of the eye cases that he had scrubbed in on. He added he was a new employee and had never sterilized cotton tipped applicators. He confirmed that none of the initials on the seal packs were his.

Based on observations, clinical record reviews, staff interviews and facility policy and procedure review the outpatient surgical services departments failed to meet the needs of the patients in accordance with acceptable standards of practice. The cumulative effect of the systemic problems regarding administration of medications (A0405), failure to have medication orders (A0406), failure to secure medications (A502), failure to provide safe surgical monitoring (A944), and failure to provide surgical services that achieve and maintain high standards of care (A0951) all resulting in unsafe practices and resulted in the outpatient surgical services not meeting this condition of coverage.
The findings include:
1. The facility failed to ensure that all drugs and biologicals were administered and/or administered in accordance with Federal regulations, professional standards and approved medical staff policies and procedures. This failure affected 6 of 15 outpatient sampled patients, #s 6, 7, 8, 10, 11, 14 and 15 as well as patients receiving care in the cardiac catheter laboratory.
2. The facility failed to obtain orders to administer intravenous (IV) fluids for 2 of 15 outpatient sampled patients, #s 13 and 14.
3. The facility failed to keep anesthetic medications secured.
4. The facility failed to provide for the safe care and monitoring of patients by having the circulating Registered Nurse (RN) also administer moderate sedation for 4 of the 15 outpatient sampled patients, #s 7,10,11,and 14. In all 4 cases there was only one RN available to both circulate and sedate, rendering the RN unavailable to effectively respond to any possible emergency.
5. The outpatient surgery departments of the facility failed to be consistent and assure the achievement of high standards of medical practice and patient care in 6 of 15 outpatient sampled patients, #s 6, 7, 8, 10, 13, and 14. In addition, the facility failed to practice acceptable standards in regards to the sterilization process of single use items.