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Based on record review and interview, the hospital failed to ensure compliance with the Condition of Participation relative to Governing Body as evidenced by:

1. Failing to ensure that the medical staff is accountable to the governing body for the quality of care provided to patients. This was evidenced by the hospital's governing body and medical executive committee's failure to initiate measures to evaluate a physicians (S11) ability to safely manage the care of surgical patients undergoing procedures documented in an external peer review including the surgical technique used to ensure compliance with acceptable standards of care when the external peer review documented that there were significant deviations from the standard of care. Deviations from the standard of care were identified in 4 of 4 peer reviews conducted on a physician (S11). (Cross reference to findings cited at A0049)

2. Failing to ensure the implementation of a system that grants surgical privileges to members of the medical staff based on competence and judgement. This was evidenced by the hospital's governing body and medical executive committee's granting surgical privileges to a physician in the absence of the initiation of measures to evaluate a physicians (S11) ability to safely manage the care of surgical patients undergoing procedures documented in an external peer review including the surgical technique used to ensure compliance with acceptable standards of care when the external peer review documented that there were significant deviations from the standard of care. Deviations from the standard of care were identified in 4 of 4 peer reviews conducted on a physician (S11). (Cross reference to findings cited at A0050)

Based on record review and interview, the hospital failed to ensure that the medical staff is accountable to the governing body for the quality of care provided to patients. This was evidenced by the hospital's governing body and medical executive committee's failure to initiate measures to evaluate a physicians (S11) ability to safely manage the care of surgical patients undergoing procedures documented in an external peer review including the surgical technique used to ensure compliance with acceptable standards of care when the external peer review documented that there were significant deviations from the standard of care. Findings:

Review of a "Timeline of Review Process" relating to S11 (OBGYN) revealed "Doctors Hospital of Slidell's review of (S11) was initiated based on a period of time of QA data, O-negative blood usage rate, extended length of stays, and an effort to maintain our blood contract in accordance with AABB standards". Documentation revealed that an external peer review of S11 (OBGYN) was conducted regarding the care and services provided to four (4) patients (Patient's #6, #5, #4, #3) who were hospitalized at Doctors Hospital of Slidell under the care of S11 (OBGYN).

The "Peer Review" was reviewed. Documentation revealed that the "Peer Review" was conducted by S12 (MD-Diplomat American Board of Plastic Surgery) and dated 11/01/10. Documentation in the "Peer Review" revealed the following:

Case 1 was relating to the care and services provided to Patient #6.

The "Case Overview" documented "(Patient #6) is a 40-year-old female who was admitted to Doctors' Hospital of Slidell by (S11), an OBGYN specialist, for an abdominoplasty and liposuction of the abdomen and flanks. Excessive bleeding developed soon after the procedure, requiring replacement of over half of the patient's blood volume. Despite a dramatic drop in the hematocrit and hypotension, (S11) did not promptly return the patient to surgery. Inappropriate medications were ordered that likely worsened the bleeding problem. The patient was eventually returned to surgery where bleeding points were coagulated. The patient was discharged on the third postoperative day".

The "Conclusion" documents "In light of the OBGYN physician's failure to appropriately manage this patient's postoperative care and by failure to return the patient to the operating room in a timely manner, there was a significant deviation from the standard of care with no impact on the patient's outcome".

Case 2 was relating to the care and services provided to Patient #5

The "Case Overview" documents (Patient #5) is a 42-year-old female who underwent mastopexies, thigh lifts, an abdominoplasty, and liposuction in an 8 hour operation on 4/20/2010. She bled excessively intraoperatively and required emergency transfusions of non-cross-matched O negative blood to bring her out of hypovolemic shock. This excessive bleeding was caused by technical inadequacies. Administration of Hespan may have contributed to this problem".

The "Conclusion" documents "Excessive intra-operative blood loss requiring emergency transfusions of non-crossmatched blood suggests that the surgeon's technique was below the standard of acceptable surgical practice. There was a significant deviation from the standard of care and a negative impact on the patient's outcome may have resulted from this deviation".


Case 3 was relating to the care and services provided to Patient #4

This "Case Overview" documents "(Patient #4) is a 53-year-old female who underwent a spiral thigh lift by an OBGYN physician, (S11), on 3/24/10. The listed estimated blood loss for the procedure was 150 ml but the drop in Hct from 41.9 preoperatively to 28.1 postoperatively suggests that the actual blood loss was much greater. The patient bled excessively postoperatively and became hypotensive. Five units of blood were transfused. The patient was discharged on the second postoperative day".

The "Conclusion" documents "The patient bled excessively during and following a thigh lift procedure due to technical inadequacies intra-operatively. Inappropriate administration of Lovenox and Hespan contributed to the problem. Central line placement and five units of blood saved the patient's life. There was a significant deviation from the standard of care and a negative impact on patient outcome is a result of this deviation".

Case 4 was relating to the care and services provided to Patient #3

The "Case Overview" documents "(Patient #3) is a 46-year-old female with an ASA class 3 was subjected to eleven and one half hours of elective surgical procedures by an OBGYN specialist and a general surgeon. She developed atelectasis and pleural effusions and required central line placement and transfusions of three units of blood. Blisters developed and the bracheoplasty (arm reduction) sites. She was discharged on the fifth postoperative day.

The "Conclusion" documents "There was a significant deviation from the standard of care and a negative impact on the patient outcome is possibly a result of this deviation".

Documentation revealed that the hospital's previous CEO (S13) forwarded the results of this "Peer Review" to the hospital's Medical Director (S7) on 11/08/10.

The hospital's Medical Director (S7) was interviewed on 4/12/11 at 1:15 p.m. When asked about the hospital's relationship with United Blood Services, S7 indicated that the hospital's relationship with United Blood Services has improved since the initiation of revised policies and procedures relating to the administration of blood. S7 reviewed the letter (dated 7/15/10) from United Blood Services informing the hospital of their intent to terminate the contract with Doctors Hospital of Slidell due to the hospital's failure to comply with AABB standards and reported that he was made aware of this notice by the hospital's previous CEO (S13). When asked about the date that he first became aware of the notice, S7 indicated that he did not know the exact date but felt sure that it was not long after the notice was received by the previous CEO. S7 confirmed that there were concerns relating to the hospital's utilization of blood and/or blood products. When asked what steps were taken by the hospital to address the concerns relating to the hospital's utilization of blood and/or blood products, S7 reported that an evaluation study was performed, policies were revised and an external peer review was performed regarding the care and services provided to four patients who were admitted by S11. When asked about the timeframe that he (S7) was made aware of the results of the external peer review, S7 provided documentation indicating that he was made aware on 11/08/10 (S7 presented a copy of the letter dated 11/08/10 sent by the hospital's previous CEO. When asked what actions were taken as a result of the external peer review, S7 presented a handwritten document dated 2/08/11 (3 months after the external peer review was received) which documented six (6) items relating to the findings identified in the external peer review. The six items were as follows:
" 1. No more full abdominoplasty on pts < Hgb 13.
2. the 4 reviewed cases is less than 1% of total cases. All 4 had good outcome.
3. Anesthesia orders Hespan.
4. Nitropaste was recommended in abdominoplasty course in Tulsa, OK.
5. Will continue to use Lovenox. It is recommended on GYN surgery.
6. Also wanted to include letter of recommendation dated August 30, 2010, to Am. Bd. Of Cosmetic Surgery>
No action taken " .
This handwritten document was signed by the hospital's Medical Director (S7). There was no documentation to indicate that all issues identified in the external peer review were addressed by the Medical Director as there was no indication that the following items identified in the external peer review were addressed with S11:
? Management of care provided to Patient #6. The external peer review indicated that there was a failure to appropriately manage the post-operative bleeding by a " failure to return the patient to the operating room in a timely manner " and by the concurrent utilization of Nitro-Bid and Lovenox as Lovenox is a form of heparin.
? Management of care provided to Patient #5. The external peer review indicated " Excessive intra-operative blood loss requiring emergency transfusions on non-cross matched blood suggests that the surgeon's technique was below the standard of acceptable surgical practice".
? Management of care provided to Patient #4. The external peer review indicated "The patient bled excessively during and following a thigh lift procedure due to technical inadequacies intra-operatively".

When asked if he could provide additional documentation to indicate that all items identified in the peer review were addressed, S7 indicated that he was unable to provide additional information to indicate that all the above issues were addressed. S7 reported that he discussed several issues with S11 but was unable to recall the details relating to the discussions with S11 and was unable to provide any documentation relating to the specific details other than the handwritten document identified above. When asked if the hospital had initiated any measures to evaluate S11's management of care of surgical patients undergoing procedures documented in the external peer review including the surgical technique used to ensure compliance with acceptable standards of care in an effort to ensure the safety of patients, S7 indicated that S11's management of care of surgical patients including his surgical technique has not been evaluated by a qualified physician during the identified procedures. S7 indicated that there was not a qualified physician who could conduct a non-biased evaluation of S11's surgical technique. S7 reported that there are only three (3) physicians at the hospital who perform the procedures listed in the peer review. S7 reported that the three physicians are himself (S7), S11, and S11's ex wife (S14). S7 reported that he and S11 are partners in medical practice and he felt it would be a conflict of interest for either him or S14 to conduct an evaluation of S11's management and technique relating to these procedures. When asked if the results of the external peer review had any effect on the delineation of surgical privileges granted to S11, S7 reported that there was no effect on the surgical privileges granted to S11. S7 reported the only action that occurred as a result to the external peer review was that there will not be any more full abdominoplasty surgeries performed on patients whose Hemoglobin is less than 13.

Review of the meeting minutes of the 2010 Medical Executive Committee revealed no documentation to indicate that information relating to the external peer review had been discussed in any of the meetings during 2010.

The hospital's Chief Executive Officer (S8) was interviewed on 4/12/11 at 2:50 p.m. S8 reported that she could provide no documentation to indicate that S11's management of care of surgical patients including his surgical technique had been evaluated by a qualified physician for the surgical procedures identified in the external peer review. S8 indicated that a decision was made by her and the Medical Director (S7) as a result of this complaint investigation to immediately suspend privileges for all medical staff for full lipo-abdominoplasty and bilateral thigh lifts until such time as surgical standards have been reviewed by a qualified peer practitioner and determined to be appropriate in the management of patients undergoing these procedures.

Based on record review and interview, the governing body failed to ensure the implementation of a system that grants surgical privileges to members of the medical staff based on competence and judgement. This was evidenced by the hospital's governing body and medical executive committee's failure to initiate measures to evaluate a physicians (S11) ability to safely manage the care of surgical patients undergoing procedures documented in an external peer review including the surgical technique used to ensure compliance with acceptable standards of care when the external peer review documented that there were significant deviations from the standard of care. Findings:

Review of a "Timeline of Review Process" relating to S11 (OBGYN) revealed "Doctors Hospital of Slidell's review of (S11) was initiated based on a period of time of QA data, O-negative blood usage rate, extended length of stays, and an effort to maintain our blood contract in accordance with AABB standards". Documentation revealed that an external peer review of S11 (OBGYN) was conducted regarding the care and services provided to four (4) patients (Patient's #6, #5, #4, #3) who were hospitalized at Doctors Hospital of Slidell under the care of S11 (OBGYN).

The "Peer Review" was reviewed. Documentation revealed that the "Peer Review" was conducted by S12 (MD-Diplomat American Board of Plastic Surgery) and dated 11/01/10. Documentation in the "Peer Review" revealed the following:

Case 1 was relating to the care and services provided to Patient #6.

The "Case Overview" documented "(Patient #6) is a 40-year-old female who was admitted to Doctors' Hospital of Slidell by (S11), an OBGYN specialist, for an abdominoplasty and liposuction of the abdomen and flanks. Excessive bleeding developed soon after the procedure, requiring replacement of over half of the patient's blood volume. Despite a dramatic drop in the hematocrit and hypotension, (S11) did not promptly return the patient to surgery. Inappropriate medications were ordered that likely worsened the bleeding problem. The patient was eventually returned to surgery where bleeding points were coagulated. The patient was discharged on the third postoperative day".

The "Conclusion" documents "In light of the OBGYN physician's failure to appropriately manage this patient's postoperative care and by failure to return the patient to the operating room in a timely manner, there was a significant deviation from the standard of care with no impact on the patient's outcome".

Case 2 was relating to the care and services provided to Patient #5

The "Case Overview" documents (Patient #5) is a 42-year-old female who underwent mastopexies, thigh lifts, an abdominoplasty, and liposuction in an 8 hour operation on 4/20/2010. She bled excessively intraoperatively and required emergency transfusions of non-cross-matched O negative blood to bring her out of hypovolemic shock. This excessive bleeding was caused by technical inadequacies. Administration of Hespan may have contributed to this problem".

The "Conclusion" documents "Excessive intra-operative blood loss requiring emergency transfusions of non-crossmatched blood suggests that the surgeon's technique was below the standard of acceptable surgical practice. There was a significant deviation from the standard of care and a negative impact on the patient's outcome may have resulted from this deviation".


Case 3 was relating to the care and services provided to Patient #4

This "Case Overview" documents "(Patient #4) is a 53-year-old female who underwent a spiral thigh lift by an OBGYN physician, (S11), on 3/24/10. The listed estimated blood loss for the procedure was 150 ml but the drop in Hct from 41.9 preoperatively to 28.1 postoperatively suggests that the actual blood loss was much greater. The patient bled excessively postoperatively and became hypotensive. Five units of blood were transfused. The patient was discharged on the second postoperative day".

The "Conclusion" documents "The patient bled excessively during and following a thigh lift procedure due to technical inadequacies intra-operatively. Inappropriate administration of Lovenox and Hespan contributed to the problem. Central line placement and five units of blood saved the patient's life. There was a significant deviation from the standard of care and a negative impact on patient outcome is a result of this deviation".

Case 4 was relating to the care and services provided to Patient #3

The "Case Overview" documents "(Patient #3) is a 46-year-old female with an ASA class 3 was subjected to eleven and one half hours of elective surgical procedures by an OBGYN specialist and a general surgeon. She developed atelectasis and pleural effusions and required central line placement and transfusions of three units of blood. Blisters developed and the bracheoplasty (arm reduction) sites. She was discharged on the fifth postoperative day.

The "Conclusion" documents "There was a significant deviation from the standard of care and a negative impact on the patient outcome is possibly a result of this deviation".

Documentation revealed that the hospital's previous CEO (S13) forwarded the results of this "Peer Review" to the hospital's Medical Director (S7) on 11/08/10.

The hospital's Medical Director (S7) was interviewed on 4/12/11 at 1:15 p.m. When asked about the hospital's relationship with United Blood Services, S7 indicated that the hospital's relationship with United Blood Services has improved since the initiation of revised policies and procedures relating to the administration of blood. S7 reviewed the letter (dated 7/15/10) from United Blood Services informing the hospital of their intent to terminate the contract with Doctors Hospital of Slidell due to the hospital's failure to comply with AABB standards and reported that he was made aware of this notice by the hospital's previous CEO (S13). When asked about the date that he first became aware of the notice, S7 indicated that he did not know the exact date but felt sure that it was not long after the notice was received by the previous CEO. S7 confirmed that there were concerns relating to the hospital's utilization of blood and/or blood products. When asked what steps were taken by the hospital to address the concerns relating to the hospital's utilization of blood and/or blood products, S7 reported that an evaluation study was performed, policies were revised and an external peer review was performed regarding the care and services provided to four patients who were admitted by S11. When asked about the timeframe that he (S7) was made aware of the results of the external peer review, S7 provided documentation indicating that he was made aware on 11/08/10 (S7 presented a copy of the letter dated 11/08/10 sent by the hospital's previous CEO). When asked what actions were taken as a result of the external peer review, S7 presented a handwritten document dated 2/08/11 (3 months after the external peer review was received) which documented six (6) items relating to the findings identified in the external peer review. The six items were as follows:
"1. No more full abdominoplasty on pts < Hgb 13.
2. the 4 reviewed cases is less than 1% of total cases. All 4 had good outcome.
3. Anesthesia orders Hespan.
4. Nitropaste was recommended in abdominoplasty course in Tulsa, OK.
5. Will continue to use Lovenox. It is recommended on GYN surgery.
6. Also wanted to include letter of recommendation dated August 30, 2010, to Am. Bd. Of Cosmetic Surgery>
No action taken".
This handwritten document was signed by the hospital's Medical Director (S7). There was no documentation to indicate that all issues identified in the external peer review were addressed by the Medical Director as there was no indication that the following items identified in the external peer review were addressed with S11:
? Management of care provided to Patient #6. The external peer review indicated that there was a failure to appropriately manage the post-operative bleeding by a "failure to return the patient to the operating room in a timely manner" and by the concurrent utilization of Nitro-Bid and Lovenox as Lovenox is a form of heparin.
? Management of care provided to Patient #5. The external peer review indicated "Excessive intra-operative blood loss requiring emergency transfusions on non-cross matched blood suggests that the surgeon's technique was below the standard of acceptable surgical practice".
? Management of care provided to Patient #4. The external peer review indicated "The patient bled excessively during and following a thigh lift procedure due to technical inadequacies intra-operatively".
When asked if he could provide additional documentation to indicate that all items identified in the peer review were addressed, S7 indicated that he was unable to provide additional information to indicate that all the above issues were addressed. S7 reported that he discussed several issues with S11 but was unable to recall the details relating to the discussions with S11 and was unable to provide any documentation relating to the specific details other than the handwritten document identified above. When asked if the hospital had initiated any measures to evaluate S11's management of care of surgical patients undergoing procedures documented in the external peer review including the surgical technique used to ensure compliance with acceptable standards of care in an effort to ensure the safety of patients, S7 indicated that S11's management of care of surgical patients including his surgical technique has not been evaluated by a qualified physician during the identified procedures. S7 indicated that there was not a qualified physician who could conduct a non-biased evaluation of S11's surgical technique. S7 reported that there are only three (3) physicians at the hospital who perform the procedures listed in the peer review. S7 reported that the three physicians are himself (S7), S11, and S11's ex wife (S14). S7 reported that he and S11 are partners in medical practice and he felt it would be a conflict of interest for either him or S14 to conduct an evaluation of S11's management and technique relating to these procedures. When asked if the results of the external peer review had any effect on the delineation of surgical privileges granted to S11, S7 reported that there was no effect on the surgical privileges granted to S11. S7 reported the only action that occurred as a result to the external peer review was that there will not be any more full abdominoplasty surgeries performed on patients whose Hemoglobin is less than 13.

Review of the meeting minutes of the 2010 Medical Executive Committee revealed no documentation to indicate that information relating to the external peer review had been discussed in any of the meetings during 2010.

The hospital's Chief Executive Officer (S8) was interviewed on 4/12/11 at 2:50 p.m. S8 reported that she could provide no documentation to indicate that S11's management of care of surgical patients including his surgical technique had been evaluated by a qualified physician for the surgical procedures identified in the external peer review. S8 indicated that a decision was made by her and the Medical Director (S7) as a result of this complaint investigation to immediately suspend privileges for all medical staff for full lipo-abdominoplasty and bilateral thigh lifts until such time as surgical standards have been reviewed by a qualified peer practitioner and determined to be appropriate in the management of patients undergoing these procedures.

Based on interview and record review, the hospital's QAPI (Quality Assurance Performance Improvement) program failed to set priorities for its performance improvement activities that focus on high-risk and/or problem prone areas. This was evidenced by the hospital's failure to identify problems relating to the utilization of blood and/or blood products until after being notified in writing by the contracted blood service provider about the hospital's practices that were not in compliance with AABB standards. Findings:

The Director of Quality Assurance (S2) was interviewed on 4/11/11 at 10:35 a.m. regarding the hospital's process for obtaining and administering blood and/or blood products. S2 reported that the hospital has contracted with Provider A out of Lafayette for blood and blood products. When asked if there have been any problems relating to the timely availability of blood and/or blood products, S2 reported that there have been instances in the past with delays in the availability of blood. S2 reported the hospital's process for obtaining and utilizing blood and blood products was changed in August of 2010 and stated that there have been no problems relating to the availability of blood and/or blood products since the implementation of this change. S2 reported that revisions were made to all hospital policies and procedures relating to obtaining and administering blood. A list of patients admitted to the hospital from January of 2010 through current date and a list of patients who have received blood and/or blood products from July of 2009 through current date was requested for review. A sample of medical records was chosen from the list provided and a focused review relating to the administration of O negative blood was conducted. This focused review revealed the following:

Patient #4 is a 53 year old female who was admitted to Doctors Hospital of Slidell on 3/24/10. The operative report (dated 3/24/10) documents Patient #4's diagnosis as Laxity of the skin of both thighs. The operative report documents that a Bilateral spiral thigh lift was performed. Documentation revealed that Patient #4 received three (3) units of packed red blood cells with the initial unit being type O negative as there was no indication of a type and crossmatch being obtained prior to the patients scheduled surgery.

Patient #5 is a 42 year old female who was admitted to Doctors Hospital of Slidell on 4/20/10. The operative report (dated 4/20/10) documents Patient #5's diagnoses as Ptosis of the breast; Mammary hypoplasia; Excess adipose tissue of the abdomen, flank, and wing area; Excess skin in the lower abdominal area; Excess adipose tissue of both thighs; and Ptosis of the skin of both thighs. The operative report documents the operations performed were 1. Vertical mastopexy; 2. Liposuction of the abdomen, flank, and wing area; 3. Excision of the excess skin of the lower abdomen; 4. Liposuction of both thighs; and 5. Horizontal thigh lift. Documentation revealed that Patient #5 received four (4) units of O negative packed red blood cells during her hospitalization. There was no indication of a type and crossmatch being obtained prior to the patients scheduled surgery.

Patient #2 is a 50 year old female who was admitted to Doctors Hospital of Slidell on 5/28/10. The operative report (dated 5/28/10) documents Patient #2's diagnoses as Excess adipose tissue and diastasis of recti muscles and Vaginal relaxation. The operative report documents the operations performed were 1. Full abdominoplasty and 2. Laser vaginoplasty and laser vaginal rejuvenation. A second operative report (dated 5/28/10) documents Patient #2's diagnoses as Urethral stenosis, Extensive pelvic adhesions, Extensive abdominal adhesions, Extensive bladder adhesions, Urinary stress incontinence, Hypermobility of urethra, Second-degree cystocele, Second-degree of rectocele, Second-degree of vaginal prolapse, and Perineal relaxation. This operative report documents the operations performed as 1. Urethral dilatation; 2. Revision of the old scar; 3. Extensive abdominal adhesiolysis; 4. Pelvic adhesiolysis; 5. Abdominopelvic antibiotic lavage; 6. Marshall-Marchetti-Krantz bladder suspension; 7. Cystoscopy; 8. Anterior colporrhaphy; 9. Pubovaginal sling; 10. Sacrospinous fixation; 11. Posterior colporrhaphy; and 12. Perineoplasty. Documentation revealed that Patient #2 received three (3) units of packed red blood cells during her hospitalization. The initial unit was O negative as there was no indication of a type and crossmatch being obtained prior to the patients scheduled surgery.

Review of documentation relating to the hospital's contract for blood services revealed that Doctors Hospital of Slidell had entered into a contract with Provider A. Review of a letter dated 7/15/2010 sent from Provider A to Doctors Hospital of Slidell revealed the following: "Please accept this letter as notification of the intent of (Provider A) to terminate the Blood Services Agreement with Doctors Hospital of Slidell. The initial agreement was dated and commenced on April 8, 2009. This letter provides the required 30 day notice of our intent to terminate the agreement on August 16, 2010. We will be in contact with your facility to pick up any blood products that are still in your possession". A "Memorandum" dated 7/19/10 was sent from Provider A to Doctors Hospital of Slidell relating to the hospital's "Transfusion Practice History". The "Memorandum" documents "per our conversation, this memo will provide details for the cases which have caused concern in transfusion practices.

(Patient #5) Date of Surgery: 4/20/10
? 2 O neg units in hospital's inventory were transfused to patient- UBS did receive a 'Transfusion Request' & 'Release for Uncrossmatched/Incomplete Blood Unit' record for this activity:
W0420 10 02029800U & W0420 1001841800O at 1615 & 1700, respectively; UBS was alerted after the units were transfused, retained segments were used to perform crossmatch.
? An additional unit, W0420 10 1846300E was obtained by DHOS from Slidell Memorial hospital, and transfused at 1730- UBS had no knowledge of this transfer or transfusion at the time- there were no segments available to perform any crossmatch activity for this unit to this patient; Additionally, there was no authorization/request for this 'release' of this uncrossmatched unit. This unit would have had no tag indicating that compatibility testing was not completed at the time of issue'.
? At some time during this afternoon, the UBS Lab Manager received a call to 'replace' the emergency-stocked 0 neg units. Unit W0420 10 020188005 was sent as a replacement. This unit was transfused at 2115, without UBS knowledge of follow-up. UBS discovered this transfusion activity on 4-22-10, and was able to pull a retained segment and perform a crossmatch- therefore crossmatch was performed nearly 48 hrs post transfusion.
? Three additional 'stat' units were requested for this patient following the transfusion of the four units indicated above (still on 4-20-10). These units were crossmatched and sent to the facility, however, none were transfused, as evidenced by their return to UBS on 4-23-10. Units involved: W0420 10 012178009 (part1), W0420 10 012189009 (part2), & W0420 10 01298900D".
? *AABB Standard 5.18.5.3: The container tie tag or label shall indicate in a conspicuous fashion that compatibility and/or infectious disease testing was not completed at the time of issue.
? **AABB Standard 5.18.5.4: Compatibility testing shall be completed expeditiously using a patient sample collected as early as possible in the transfusion sequence. Standard 5.17.5 applies.

(Patient #2) Date of Surgery: 5-21-10
? (1) emergency released O neg unit was transfused on 5-28-10.
UBS was not notified of this transfusion on 5-28-10** Crossmatched upon discovery.
(2) additional units were ordered stat and crossmatched by UBS, also on 5-28-10.
Paperwork in order for this case.
? **AABB Standard 5.18.5.4: Compatibility testing shall be completed expeditiously using a patient sample collected as early as possible in the transfusion sequence. Standard 5.17.5 applies."

The hospital's QAPI (Quality Assurance Performance Improvement) data was reviewed. Review of the meeting minutes for the QAPI meetings dated 1/29/10, 4/21/10 and 5/27/10 revealed no documentation to indicate that the hospital had identified and implemented corrective action relating to concerns and/or breaks in the AABB Standards as documented above. Further review revealed the breaks in the AABB Standards were not identified through the hospital's QAPI program until after being notified by Provider A.

The hospital's Director of Quality (S2) was again interviewed on 4/11/11 at 1:45 p.m. When asked if the hospital's QAPI (Quality Assurance Performance Improvement) program had identified concerns and/or breaks in the AABB Standards (as documented above) relating to the utilization of blood and/or blood products prior to receiving the letter from Provider A informing them of their (Provider A) intent to terminate the Blood Services Agreement with Doctors Hospital of Slidell, S2 indicated that the problems relating to the utilization of blood and/or blood products were not identified prior to receiving the notice from Provider A. S2 reported that an evaluation study was performed after receiving notice from Provider A and indicated that all hospital policies/procedures relating to blood and/or blood products were revised in August of 2010 to ensure compliance with AABB Standards. S2 also reported that an external peer review was performed regarding care and services provided to 4 patients who received blood during their hospitalization. Upon review of the external peer review, the external peer review documented that there were significant deviations from the standard of care. When asked if she could provide information to indicate that all issues identified in the external peer review were addressed by the hospital's governing body and medical executive committee, S2 was unable to provide information to indicate that all areas were addressed by the hospital's governing body or medical executive committee.