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Standardizing Standard Operating Procedures' (SOP) Manual to Benchmark

Cell Processing Laboratory (CPL) Performance

Article  in  Biology of Blood and Marrow Transplantation · February 2013

DOI: 10.1016/j.bbmt.2012.11.388

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Morris Kletzel Marcelo Villa

Northwestern University Northwestern Memorial Hospital
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Northwestern University
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S276 Abstracts / Biol Blood Marrow Transplant 19 (2013) S257eS278

The Sarah Cannon Blood Cancer Network (SCBCN), consisting performed over 100 transplants per year. When asked about
of 5 FACT accredited HCTP, analyzed Medicare claims data training to become a DM, 51% reported having less than 1
submitted by SCBCN between 1/1/11 and 12/31/11. 120 HCT week of training and 88% reported not being extremely
were performed on 119 patients (pts): 69 men and 50 satisfied with his/her DM training. Thirty percent had no
women, median age 67 years (range 28-79) with Multiple previous experience with BMT-related information when
Myeloma (62), Lymphoma (35), Acute Leukemia (17) and they became a DM and most (53%) were not audited prior to
other (5). There were 23 allogeneic (allo) HCT (MS-DRG-14), independently completing CIBMTR forms. Training to
2 of which were outpatient with an average length of stay complete CIBMTR forms ranged from none to training
(LOS) of 30 days (0-123) for related and 25 days (5-55) for received from multiple sources. At the time of the survey,
unrelated; 12/23 were < 20 days. Inpatient coding for 54% were not familiar with the current CIBMTR training
autologous (auto) HCT was split among three MS-DRG model.
because of a change in 2012 from MS-DRG- 15 (71) and to Conclusion: The CIBMTR DM Training Methods Survey
MS-DRG 16dwith complication/comorbidity (cc) (18) and shows that CIBMTR DMs vary by age, previous experience,
MS-DRG 17dwithout cc (8) with average LOS 18 days (2-39); and levels of training. Based on the data, it is evident that
55/97 were <20 days. Of 18 pts assigned DRG16, all appeared a training model, which incorporates specific procedures and
to have codes supporting increased complexity. Of 8 pts methods, would be of value to CIBMTR DMs and the data
assigned DRG17, 5 had codes that might have supported they report. Standardized DM training would improve the
billing under DRG 16. Among 23 allo pts, 7 were missing the accuracy and quality of data, which would contribute to the
code defining donor source as related or unrelated including knowledge learned from hematopoietic stem cell transplant
both patients who received outpatient allo HCT. Revenue research.
code 819, which reports charges for donor cell acquisition,
was reported in 18 cases with a 40-fold variance in range of
charges. Interestingly, this code was also submitted in 46 of
97 auto cases.
Conclusion: Significant opportunities may exist for using 333
the proper MS-DRG for auto pts (which has substantial Standardizing Standard Operating Procedures' (SOP)
revenue implications) and the use of revenue code 819 for Manual to Benchmark Cell Processing Laboratory (CPL)
allo HCT (which has substantial implications for future rate Performance
setting). Programs can significantly increase future Mehboob Merchant 1, Morris Kletzel 1, 2, 3, Marcelo Villa 1,
payment rates by understanding their current Medicare Thomas Shook 1, Leo I. Gordon 1, 4. 1 Cell Therapy Processing
billing practices and identifying opportunities for Facility, Northwestern Memorial Hospital, Chicago, IL;
2
improvement. Further investigation will focus on estima- Northwestern University Feinberg School of Medicine,
tion of costs as compared with reimbursement for Medi- Chicago, IL; 3 Ann & Robert H. Lurie Children's Hospital of
care beneficiaries. Chicago; 4 Northwestern Univ Medical School, Div of Hem/Onc,
Chicago, IL

Background: Healthcare SOPs are now standardized. There

are a few hundred routine CPL policies/procedures (P/P) and
332 maintaining SOP Manual (SOPM) becomes a daunting task.
CIBMTR Data Management Training Survey 2012 SOP of any two labs would not only differ on how to achieve
Theresa M. McKay, Kathleen Ruehle. University of Maryland the same task but no two SOPM would equally cover all
Greenebaum Cancer Center, Baltimore, MD topics required by regulatory and/or accrediting agency
(R/AA).
Purpose: Effective training of data managers (DM) is Amongst the R/AA, JC, OSHA, CLIA, CAP, AABB, FACT & FDA
instrumental to assure accurate, quality data. The National all have oversight claims on the lab, including lab practices
Marrow Donor Program (NMDP) and the Center for Inter- and SOPs. Failure to abide may result in catastrophic
national Blood and Marrow Transplant Research (CIBMTR) outcome from citation to shut down and insurance
network provide training resources and liaisons for each disapproval.
transplant center in order to assist in proper completion of Objective: R/AA have common minimum standards-
the CIBMTR data collection forms. The University of Mary- patient safety is the prime concern, and it may be possible
land Greenebaum Cancer Center's (UMGCC) Blood and to standardize R/AA requirements so that SOPM for every
Marrow Transplant (BMT) team utilizes the CIBMTR elec- CPL is identical in content, achieving uniformity across the
tronic training resources and liaisons, as well as other alter- board.
native training methods. Our team was interested in Methods: In 2008, our CPL had a management change
assessing the effectiveness of DM training methods and to and became an independent lab with a cGMP facility. We
enhance the CIBMTR DM training model. inherited SOPs from two departments, a total of 161
Method: The UMGCC BMT team developed an anonymous, policies plus 204 forms. There was confusion and dupli-
twenty-question survey on the various training methods cation with two dissimilar SOPs and formats, also
implemented at 138 NMDP and CIBMTR-affiliated transplant previous P/P had not been updated to current regulatory
centers in the U.S. The survey consisted of quantitative and guidelines.
qualitative questions pertaining to demographics, prior DM Early in 2010, we merged the two sets into integrated,
experience, and training. practical and regulatory-compliant documents with novel
Results: Seventy DMs responded to the survey. Participant formatting to distinguish one from the others. FDA regula-
ages were well distributed with 29% of participants 18 to 34 tions took precedence over other R/AA.
years, 39% 35 to 49 years, and 33 % 50 to 64 years. Most FDA, FACT, CAP and the JC's guidelines were keenly
respondents (66%) reported that they had been a CIBMTR DM scrutinized prior to addressing the merger. SOPs were sorted
for greater than 5 years. Half (51%) participated in monthly into three broad categories: Quality Management, Cell Pro-
internal assessments and 57% worked at centers that cessing and cGMP.
 Abstracts / Biol Blood Marrow Transplant 19 (2013) S257eS278 S277

Result: During the course of this merger, we concluded that variation. Information on HCT coverage benefits for 2012
only one cGMP policy was required since GMP users had was collected from state Medicaid websites and was
their own program SOP. However, GMP users would be compared to the recommendations for minimum benefits
trained in QM policies besides their own P/P. Our current that have been developed by the National Marrow Donor
SOPM has 70 P/P, 81 forms & 3 presentations, covering all Program in collaboration with physicians, transplant
areas of processing and is compliant with R/AA. centers and payors (www.marrow.org/payor). Data was
Conclusion: Our rationale for standardizing SOPM is based coded on a three point scale depending on whether indi-
specifically on 21 CFR Part 1271 which governs all CPLs and is vidual state coverage met minimum benefits criteria (score
mandatory law. With standardization, we will have clarity, 2), provided some but not minimum benefits (score 1), or
identical training for staff, and assurance of adherence to did not provide any benefits (score 0) for the following 5
similar methodology as required by law, resulting in categories: 1) transplant procedure and disease indications,
consistency, uniformity, legitimacy and safety in our labo- 2) donor search, 3) medications, 4) clinical trials, and 5)
ratory manufactured products. patient food, lodging and transportation. Data were avail-
able for 47 states (Figure 1). No state provided minimum
coverage benefits in all 5 categories and only three states
P/P Title Sub Titles Forms
met the minimum in 4/5 categories. Our study highlights
substantial variation in Medicaid coverage by state for HCT
I. Q M
1. Quality Assurance Organization; Terminology
which may serve as a barrier to access to HCT for some
2. Good Manufacturing patients. In light of the Affordable Care Act and the deter-
3. Responsibilities Lab Tech to MD mination of Essential Benefits by individual states,
4. Security & Safety Safety manual etc 2 a common framework for complex medical procedures
5. Utility Mgmt Air Handling; Compressor; etc 12 such as HCT may be beneficial.
6. Training Training; Competency; CE 2
7. S.O.P. Mgmt Writing; Controls 5
8. Systems Controls; Validation 5
9. Event Mgmt 2
10. Audit 1
11. Equipment Mgmt BSC; Incubator etc; PM etc 7
12. Accreditation Mgmt 5
13. Supplies 2
14. E M Mgmt 4
15. Cleaning, Sanitization 2
16. Data Mgmt Documentation; Billing
II. Processing
1. HCT/P Quality Assurance Donor, Patient, Product 3
2. Quality Testing 1
3. Chain of Custody 3
4. HCT/P Manufacturing From Receipt to Infusion 20
5. Data Mgmt
6. Equipment Ops Cobe 2991; Cell Counter etc 5
III. cGMP
1. Gowning Figure 1.

334 335
Substantial Variation in Medicaid Coverage for The Benefits of Metadata Analysis and Form Question
Hematopoietic Cell Transplantation Harmonization
Jaime M. Preussler 1, Stephanie Farnia 2, Ellen Denzen 3, Sandra Sorensen, Robinette Renner. CIBMTR - IT, National
Navneet S. Majhail 2. 1 Patient Services, Natoinal Marrow Marrow Donor Program, Minneapolis, MN
Donor Program, Minneapolis, MN; 2 National Marrow Donor
Program, Minneapolis, MN; 3 Patient Services, National Background: In order to collect high-quality data from
Marrow Donor Program (NMDP) multiple organizations, there must be a clear understanding
as to what data is needed and how it is to be reported.
Medicaid is a jointly funded federal-state program that Metadata, often described as “data about data,” describes
provides payment for health services for pregnant women, the content, quality, and other attributes of the data being
children, parents, seniors and disabled individuals. States collected. These attributes include maximum length,
establish and administer their own Medicaid programs and number of decimal places, data type (character, number, or
determine the type, amount, and scope of services within date), multiple choice answer vs. free text, etc. Historically,
federal guidelines which mandate coverage of certain FormsNet (FN), the Center for International Blood and
benefits. Optional benefits that can be provided by the state Transplant Research's (CIBMTR) electronic data capture
can lead to a wide variation of benefits offered. Hemato- system, stored the metadata at the question level. Since
poietic cell transplant (HCT) is not a mandatory covered data collection forms were created independently, differ-
service for adults, and each state has the discretion to ences in question design and metadata became problem-
choose whether to cover it and the extent of the coverage. atic. For example, primary disease is a list of valid values on
Variation in state policies can impact access to care for one form and free text on another. In an effort to improve
patients. At the same time, many patients rely on Medicaid data quality and facilitate analysis, the use of well-defined
for HCT coverage e according to HCUPnet data, Medicaid metadata and data standards, took on a more prominent
paid for 3,064 HCT hospitalizations (16% of HCT discharges) role.
in the US in 2010. A national comparison of Medicaid Methods: Common data elements (CDE) were created using
coverage for HCT was undertaken to learn more about state the National Cancer Institute's Cancer Data Standards

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