Guidance for Documentation of Therapeutic Apheresis Interventions in the Medical Record: An American Society for Apheresis (ASFA) Practice Perspective

ABSTRACT

In 2007, the American Society for Apheresis (ASFA) published guidance for physician documentation related to oversight of therapeutic apheresis (TA). Due to 21st century changes in healthcare delivery, the ASFA Board of Directors (BOD) charged its Public Affairs and Advocacy Committee (PAAC) to coordinate a review and update of the guidance. PAAC members reviewed minutes from various ASFA committees' earlier deliberations and sought additional information from the medical and general literature and regulatory/professional organizations involved with medical records documentation as well as from ASFA membership. A draft document was developed, reviewed, and approved by pertinent parties with changes incorporated into the guidance revision. Major change agents impacting TA documentation were identified including the importance of multidisciplinary care teams, the adoption of telemedicine in TA delivery, and the challenges highlighted by the SARS‐CoV‐2 pandemic. Formats involving TA documentation scenarios related to initial TA consultations and subsequent care activities by TA staff were developed. The introduction of new technologies, the advancing and mandating of electronic medical records (EMRs) adoption and a renewed emphasis on the team‐based nature of healthcare delivery have all impacted TA services. Revised documentation formatting practices related to these changes, not only for physicians' involvement but recognition and inclusion of other members of multidisciplinary teams participating in TA, should be incorporated into TA operations. Such revisions can potentially enhance patient care and provide a foundation for TA‐related biovigilance activities.

1. Introduction

In recognition of the importance of the documentation of therapeutic apheresis (TA) procedures in a patient's medical record, the American Society for Apheresis (ASFA) circa 2005–2007 developed guidance for pertinent documentation related to a physician's provision of oversight services during a TA procedure [1]. Such guidance was intended to be periodically reviewed by members of ASFA's Board of Directors (BOD). Such reviews were to be conducted by the BOD alone, or in collaboration with a designated ASFA committee, followed by BOD approval. Updates were to be made based on changes in TA practice environments brought about by technological advances in apheresis medicine, patient safety considerations, and regulatory/accreditation agencies' expectations regarding TA procedures.

Since the initial guidance publication, much has changed in medicine and its clinical practice environments, not the least of which have been the introduction of new technologies, including the advancing and mandating of electronic medical records (EMRs) adoption and a renewed emphasis on the team‐based nature of healthcare delivery. The COVID‐19 or SARS‐CoV‐2 pandemic has added yet another dimension and logistical complexities to all the previously cited areas, yielding new and challenging considerations in the care of patients receiving TA treatment.

In recognition of these as well as other changes in healthcare delivery in the 21st century, the ASFA BOD charged several of the Society's committees to review, comment on, and update the original Guidelines document eventually requesting that the Society's Public Affairs and Advocacy Committee (PAAC) coordinate the review and provision of pertinent updates where appropriate. Here we present the results of those deliberations of the PAAC as approved by the ASFA BOD.

2. Materials and Methods

In 2021, the ASFA Board of Directors directed its Public Affairs and Advocacy Committee (PAAC) to formally review and revise, where pertinent, guidance materials regarding physician documentation of TA activities. Although not formally charged in prior years with this task, the Committee nevertheless had frequent discussions regarding this topic among its various agenda items with respect to the opportunities for telemedicine in apheresis (telapheresis). Based on this background, PAAC leadership decided to approach the directive using a strategy like one used as previously described [2]. Briefly, PAAC members reviewed minutes from earlier deliberations on the topic by various ASFA committees as well as seeking information via web‐based searches from the medical and non‐medical general literature and regulatory and professional organizations involved with medical records documentation, especially as pertinent to TA activities. Input regarding the topic was further elicited from individual ASFA members actively involved in addressing documentation strategies in their practice environments, including but not limited to academic medical centers, blood donor centers, and organizations providing mobile apheresis services to multiple hospitals in a defined geographic area.

Recognition of the importance of multidisciplinary teams in healthcare delivery, including TA, was also identified as a practice trend by the group and incorporated into an expanded discussion of the original goal. Importantly, the rapid advancement of telemedicine and the related area of telapheresis, both due in large part to the SARS‐CoV‐2 pandemic (having markedly impacted the clinical landscape of healthcare delivery), were also identified as major change agents that needed to be addressed. A draft document was developed and shared with the Committee, with discussions of its contents (via email communications and teleconferences) over several months' time with input incorporated into a revised draft. This document was then presented to the ASFA Board of Directors for additional review, commentary, and approval, after which the revised draft was directed back to the PAAC for the preparation of a manuscript incorporating the guidance for publication.

In this regard the BOD specifically suggested that many of the various documents developed by the PAAC were also pertinent and applicable for TA practitioners other than physicians, for example, Advanced Practice Providers (APP) in their documentation of the TA care event. Although the mission of the PAAC's deliberations over its multi‐year discussions were focused predominantly on the physician's role in documentation, given the evolving roles of APP in healthcare and TA that have emerged over the interval of the PAAC's deliberations, the committee endorsed this suggestion. In this respect, therefore, for the purposes of clinical documentation and charting, the PAAC recognizes that APPs may be interested in using the various note formats identified in this manuscript where pertinent and per individual healthcare institutions' practices, policies, and documentation culture.

3. Results

3.1. The Landscapes of Apheresis Medicine Clinical Care Maps

In general, Apheresis Medicine (AM) interventions can be viewed through two lenses: one narrowly specific and solely related to the individual “extracorporeal care event” session itself, that is, a “practitioner procedural perspective” focused on the actual process of TA and devices used in the intervention, and a second more widely encompassing one related to the “extracorporeal care episode” that also is inclusive of the TA event itself, that is, a “practitioner cognitive perspective” focused not only on a TA session but also on the continuum of care provided by an AM specialist before and/or after the actual TA intervention, typically over a specified time interval [3]. Both perspectives include a physician cognitive aspect; data components pertinent to each can best be appreciated when a clinical care map for TA is constructed (Figure 1) [4].

FIGURE 1.

One example of a therapeutic apheresis (TA) care map depicting major phases of peri‐apheresis activities with various diagnostic and therapeutic activities associated with them, as well as the multiple clinical entities and the roles individual practitioners may have in them. Note the intersectionality areas involving various entities which in themselves may have different care map perspectives. It should be noted that involvement of a blood bank is not always required in certain TA procedures, for example, in cellular depletions or where albumin fluid replacement is used. Intravenous access assessment and education of the patient are also aspects of Phase IA. Patient identification/specimen checks may also be parts of the time out procedure in Phase IB. Exact time periods for the various phases have not been identified since these intervals likely differ based on individual institutional perspectives and patient case complexities. For example, Phase 1A may occur over several days/weeks prior to TA especially for elective consultative cases, whereas Phase 1B activities would occur typically on the day of apheresis. The exact time interval for Phase IIIB can vary from days to years depending on the particular adverse complication, what medications may have been used in the peri‐apheresis interval, and whether non‐albumin blood products were included as replacement fluids, for example, semi‐acute medication reactions, immune alloimmunizations, infectious agent transmissions, iron overload, and so forth. In this regard individual TA services should partner closely with their facility's blood bank and pharmacies. A “lag reaction” can be defined as a suspected adverse event potentially related to the TA procedure that occurs after the ending of the TA intervention up to approximately 24–36 h post‐TA completion. Additional activities not depicted on the care map should be considered per institutional clinical practice cultures and guidelines. Admin, administration; AM, apheresis medicine; AMS = Apheresis Medicine Service; H&P, history and physical; HCPs, health care providers; IV, intravenous; MD, MD/DO physicians or other pertinently trained/degreed physicians; PRN, as needed; QI, quality improvement; SPARs, suspected procedural adverse events; VSV, vital sign values.

Clinical care maps are well known in nursing practice and, along with checklist strategies, are beneficial in optimizing the care delivered to patients. Using such a generalized TA care map as a starting point, major diagnostic, therapeutic, and clinical management activities related to TA can be identified and assessed for their potential benefit, utility, and incorporation as data elements into various documentation formats related to both the “TA care event” and the “TA care episode.” They can also serve to identify key personnel involved in the delivery of that care and thus can be helpful in improving clinical communications including with patients and their families (Figure 1).

Using the AM clinical care map as a touchstone, with the perspective that a variety of documentation formats may be involved in TA (several of which may not be currently used by AM practitioners in their individual settings and/or available in their respective patient electronic medical record formats), the committee decided to focus its efforts on seven format scenarios: (1) the TA Initial Consultation Note; (2) the TA Nursing Procedural Note; (3) the TA Physician/Staff Multi‐Author Progress Note; (4) the TA Interval Progress Note; (5) the TA Procedure Deferral Note; (6) the TA End of Service/Discharge Summary Note; and (7) the Post‐TA Series Follow‐up Service Note. Importantly, although it was recognized that these seven format scenarios may be reflective and highly effective in their totality in comprehensively communicating the efficacy of a course of TA treatments, the group's members acknowledged that the thoughtful selection of only two or three of the specific note types may be sufficient for the documentation of high‐quality clinical care delivered in many TA interventions.

3.2. TA Initial Consultation Note

The TA Initial Consultation Note was thought best to be predicated on the Evaluation and Management Consultation Note format. The scope of what should be included in such a note was recognized to potentially vary between individual practitioners and between institutions, but a comprehensive pertinently focused approach, rather than a “laser‐focused one‐and‐done” evaluation, was thought to have merit and should be considered, especially for patients presenting with complex immunological co‐morbidities. An example derived from one institution's documentation is depicted in Figure 2. Several examples of various other types of TA procedure notes involving initial, ongoing service, end of service, and follow‐up consultation notes can be found in e‐Supplemental Files [Link], [Link], [Link], [Link], [Link], [Link], [Link], [Link]. Readers are also referred to various publications for further insights into what may be relevant to include in such documentation [5, 6, 7, 8, 9]. A note format of this type, with pertinent rationales cited, could also serve as a documentation avenue if a requested TA procedure or series is deemed not to be indicated for or in the best interests of the patient based on the clinical situation at the time of the TA consultation.

FIGURE 2.

One potential note template example for Red Cell Exchange procedure. Depiction is a synthesis of various formats submitted by the authors. Data elements included in the model may vary from different institutional perspectives.

3.3. TA Nursing Procedural Note

A note of this type was viewed as being a critical source document containing all the required documentation of elements related to regulatory and accreditation agencies' concerns pertinent to the TA session, especially with respect to apheresis devices and related equipment that were used during the procedure (e.g., blood warmers) and for the recording of lot numbers for the various plasticware kits and consumables used during the event. Such a note would also contain information regarding start/stop times, patient vital sign values during the TA procedure (per institutional policies) and the recording of any unexpected or adverse events encountered. Inclusion of such data would help inform the construction of the TA Physician/Staff Multi‐Author Progress Note (see below) as well as provide a source for data relating to quality improvement/control and biovigilance activities, the recording of such data being especially critical if any lookback notifications are subsequently received by the hospital or Apheresis Medicine Service (AMS). Excerpts from one such document in use at a hospital where TA procedures are performed is shown in Figure 3A,B. The use of checklist formats in this type of document may also be of value, not only for the indicated functionality depicted in the document excerpts, but in the capture of data through the discrete task assay (DTA) fields in which the various data elements are recorded [5].

FIGURE 3.

Computer‐screen displays of select sections of an apheresis nursing procedural note documented in a patient's electronic medical record (PEMR) used at one of the authors' institutions. The note is constructed in a “flowcharting” manner mirroring the temporal activities associated with the therapeutic apheresis procedure. In this “scrolling document” format, data such as vital sign values (VSVs), are placed into various discrete task assay (DTA) fields by nursing staff which are then used by the hospital's computer system to automatically calculate derived VSVs, for example, pulse pressure and time interval “delta values” associated with the procedure (A). Periodic charting of VSVs when replacement fluids, such as plasma, are used in the procedure, as well as the recording of routine various run parameters, occur at defined “Run Times” per the service's standard operating procedures (B).

3.4. TA Physician/Staff Multi‐Author Progress Note

With respect to AM physician documentation in basic TA progress notes, Committee members believed that among a “Commendable Practices” approach, such notes, at a minimum, should incorporate documentation and attestation of at least the following four elements related to a physician's involvement in the TA event: (1) the physician reviewed and evaluated the pertinent clinical and laboratory data relevant to the treatment of the patient in the peri‐apheresis interval (i.e., prior to, during and/or after the TA intervention with temporal intervals being defined by the individual provider's service/institution); (2) the physician made the decision to perform the therapeutic procedure on the selected day; (3) the physician “saw and evaluated” the patient for the procedure, which should be interpreted as to include not only any direct face to face clinical encounters, but also the use of any bidirectional interactive audiovisual telemedicine communications formats, that is, telapheresis as well; and (4) the physician remained available either in‐person, via a telapheresis format, or through a designated on‐site colleague, to respond to situations arising throughout the duration of the procedure.

These four points establish that the TA procedure was carried out under the physician's supervision and orders. They serve as minimal guide points for recognizing a physician's involvement in the TA care event as documented in a clinical procedure/progress note. As described, the documentation note does reference the review of the pertinent clinical and laboratory data that the TA physician should consider while managing a patient prior to, during, and/or post procedure. These guide points, however, do not directly specify how they are to be documented or how such a note should be formatted, only indicating that the points need to be properly referenced in some manner or institutionally specific verbiage. As such they are essentially benchmarks of the clinical activities, themselves potentially serving, if so desired, as targets in the development of quality improvement (QI) metrics for an AMS. Potential examples of Apheresis Medicine Physician Attestation Statements for their clinical notes are shown in Table 1.

TABLE 1.

Potential examples of acknowledgments of supervisory attestation documentation by Apheresis Medicine Service (AMS) physicians related to therapeutic apheresis procedures.

Direct face to face patient clinical encounters: AMS Attending Attestation: I have seen and evaluated this patient. I have discussed the case and its management with the AMS Resident and agree with the findings and plan as documented in the AMS Resident's Note. Remote/telapheresis clinical encounters: AMS Attending Attestation: I have reviewed the patient's medical history, findings on examination, diagnosis, and treatment. I have discussed the case and its management with the AMS Resident and agree with the findings and plan as documented in the AMS Resident's Note. This evaluation was performed via a Telapheresis consultation format. AMS Virtual Telapheresis Subject Matter Expert Co‐Attending Attestation: I have reviewed the patient's medical history, findings on examination, diagnosis, and treatment. I have discussed the case and its management either with the Primary AMS Attending and/or the AMS Resident/Staff and agree with the findings and plan as documented in this multi‐author AMS Team Note. My evaluation was performed via a Telapheresis consultation format. Either types of clinical encounters: Supervising AMS Attending Physician Attestation: I have reviewed the patient's medical history, findings on examination, diagnosis, and treatment and reviewed and evaluated the available pertinent clinical and laboratory data relevant to the treatment of the patient on the day of the procedure and/or in a reasonable time interval prior to the Therapeutic Apheresis (TA) session. Based on this evaluation I determined that the decision to perform the TA procedure on the indicated days scheduled for the intervention(s) was reasonable. I attest that I either directly saw and evaluated the patient for the procedure in a “face to face” encounter or interacted with the patient and pertinent Apheresis Medicine Service (AMS) staff in a remote two way interactive telemedicine communication encounter (i.e., “Virtual Supervisory Telapheresis Format”) at some time point during the TA intervention/peri‐procedural timeframe. I acknowledge that I was available to respond either in‐person, via a Telapheresis format, or that a designed entity, e.g., hospital Rapid Response Team or “Educated Colleague” (as defined by the American Society for Apheresis), were available on‐site to address situations requiring a supervisory physician's input throughout the duration of the procedure. I also acknowledge that I have discussed the patient's case and management with the AMS resident/staff and agree with the findings and plan as documented in this multi‐author AMS Team Note. This evaluation (was/was not) performed via a Telapheresis consultation format. AMS Attending Attestation: Patient not personally seen by me, however, case discussed with pertinent medical/nursing staff providing care for the patient. I have also discussed the case and the patient's management with the Apheresis Medicine Service team and agree with the findings and plan as documented in the AMS Team Note. Attestation signed by MD/DO at Date/Time. I saw and evaluated the patient (in‐person or via a Telapheresis consultation format). See the Resident/Fellow's Note for details. I agree with the findings and plan of care as outlined except as noted below: XXXX. Clinically appears … Goal (…) was able to achieve with some improvement in status. No changes to therapeutic apheresis plan today. Discussed with the clinical team. A total time of XX minutes was spent on this encounter including the above activities.

Just as importantly, the Committee believed that although a note of this type could be restricted to physician and/or APP input only, a potentially more comprehensive and clinically integrative practice would be to include identification and input, where applicable, of all individuals involved in the TA session. Such an approach accomplishes several goals, not the least of which includes documentation of contributions by involved graduate medical house staff and nursing colleagues. Identification of various attending staff involved and their respective roles, if included, may also serve as a document source used in hospital credentialing, especially for new members' services on‐boarding and/or hospital re‐credentialing purposes. As such it forms a go‐to “rapid path” for a summation of the event while also offering insight into future therapy plans and scheduling. See eSupplemental File #3 for one possible example of this type of note.

The Committee also recognized that the option of using a multi‐author note format may not be currently feasible at every institution depending on its information technology (IT) constraints and its available electronic medical records formats. Given these logistical limitations, in institutions where a multi‐author note cannot be accomplished, the use of single author notes should not be considered a sub‐optimal or sub‐standard practice.

3.5. TA Interval Progress Note

Documentation of this type of charting (See eSupplemental File #5) was thought to be pertinent for use on non‐TA procedure days, for example, when evaluating a patient between TA interventions when the AMS Attending Physician is consulted by medical staff managing the patient in either an inpatient or outpatient setting regarding TA‐related adverse effects, diagnostic testing issues, scheduling changes, and so forth. Alternatively, it was also considered to be useful if it was the AM physician's routine practice to periodically ‘round’ on the Service's inpatients on “off treatment days” to become aware of and ensure that major changes in the patient's clinical status have not occurred that could potentially impact the TA treatment plan. Such a note could also serve as a documentation record of the physician's initial efforts, and those of a referring colleague, in attempting to establish a role for TA in the management of the patient's disease before embarking on a TA series, especially with respect to gaining approvals from third‐party insurance providers.

3.6. TA Procedure Deferral Note

Documentation of procedure cancelations and deferrals was considered useful in gaining insights into activity and productivity aspects for an AMS as well as offering the ability of individualizing patient care plans, especially if a patient is a frequent “no show” and may benefit from a scheduling change. Documentation of such information may also provide data for capture metrics to improve AMS efficiencies and patient satisfaction responses that may be part of a hospital quality monitoring program. See eSupplemental File #6 for details.

3.7. TA End of Service/Discharge Summary Note

Documentation of end of service activities was viewed as providing opportunities to summarize events and outcomes related to the TA interventions. Summarizing various data elements pertinent to individual TA sessions, for example, total blood volumes processed/removed/replaced along with replacement fluids used and the occurrences of any adverse events is useful from many perspectives including but not limited to the potential return of a particular patient as well as the treatment of patients with similar pathologies who may benefit from a similar TA intervention were identified as potential metrics to include in the communication. Such data may also be useful in any intra/inter‐institutional research endeavors that an AMS may wish to participate in. See eSupplemental File #4 for details.

3.8. Post‐TA Series Follow‐Up Service Note

Frequently, after a patient is discharged from an AMS, no further contact with that individual typically occurs unless requests are received from referring providers for a repeat series of TA treatments especially if disease relapse occurs acutely. Depending on the individual AM services, however, the ability to “follow‐up” with a discharged patient, either in an in‐person (“face to face”) or telemedicine encounter, can be extremely valuable. If for no other reason, the knowledge gained from such encounters can help inform strategies regarding patient management (clearly at the local level but potentially also in a wider geographic scope) of the intervention and the benefit, or lack thereof, in future clinical consultations with that patient or with patients with similar pathologies. Such approaches require good coordination of data capture and analyses if they are to be valuable in assessing the role of TA in the treatment of established disorders or in emerging indications, and a note of this type was considered to be of multi‐functional value and utility. See eSupplemental File #7 for an example of one possible note of this type.

3.9. The Value and Use of Coded Comments

As aids to documentation, the Committee believed that not only were certain documentation format templates of value but also believed that the incorporation of frequently used pertinent textual comments in the various TA documentation formats was beneficial from several perspectives. These included, but were not limited to, easier and more time‐efficient and rapid recording of the TA intervention and potentially serving as touchpoints in uniformity and taxonomy of certain commonly encountered documentation scenarios that could further serve in quality metrics data capture for quality improvement, patient safety, biovigilance monitoring and reporting, billing/reimbursement, and clinical research purposes. A partial listing of some coded comments that AM services may wish to consider in their documentation is shown in Table 2.

TABLE 2.

Selected potential coded comments pertinent to Apheresis Medicine Services' documentation activities.

Excerpt from Therapeutic Plasma Exchange (TPE) Note for a Patient with Autonomic Nervous System Instability: “… As discussed in our initial consult, due to concerns regarding autonomic nervous system instability, we have elected to pursue a “ramp‐up” Therapeutic Plasma Exchange (TPE) strategy with respect to the volumes of plasma we remove during a TPE session increasing the volume removed as tolerated up from an initial target of 0.50 plasma volume to our typical 1.0 plasma volume target. The second session of TPE treatment will be done tomorrow targeting a 0.75 plasma volume for removal …” 2 Excerpt from TPE Note for a Patient with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): “… Apheresis Medicine Service (AMS) Medical Staff Note: Performed Xth Therapeutic Plasma Exchange (TPE) in an initial series as an inpatient at the patient's bedside. Tolerated well without complications. Patient continues to demonstrate positive but slow improvement. Next TPE is scheduled to occur on XXX. Case discussed by Dr. A with Dr. B on XXX. Since patient appears to be improving with TPE, a series extension seems reasonable. Would target this follow‐on series to begin on Friday XXX. Strategy for this TPE intervention would be as follows: Total plasma removal target of 250 mL/kg (~20 L) to be done over an extended period in a tapering manner with targeted intravenous immunoglobulin (IVIg) infusion after select TPE sessions. Would begin first session in this series on Friday then Monday and Wednesday of next week. IVIg infusions after Friday and Wednesday sessions. Holiday hiatus (likely discharge to Skilled Nursing Facility (SNF)) with subsequent return to hospital as an inpatient admit during the first week in XXX with TPE sessions on Tuesday/Thursday of that week. IVIg infusion after Thursday session. Additional sessions to be determined based on clinical response with lengthening of taper interval to continue as clinically tolerated and with respect to observed degree of benefit from TA. Intravenous access device (IVAD) care will need to be arranged and performed per AMS protocols by staff at SNF until full assessment of patient's peripheral vascular access can be assured and demonstrated to be a stable option. Attending Attestation: I have reviewed the patient's medical history, findings on examination, diagnosis, and treatment. I have discussed the case and its management with the AMS resident/staff as well as speaking with the patient and agree with the findings and plan as documented in this multi‐author AMS Team Note …” 3 Excerpt from TPE Note for a Patient with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): “… Apheresis Medicine Service (AMS) Medical Staff Note: Performed XXth Therapeutic Plasma Exchange (TPE) in an ongoing series as an outpatient in our unit. Patient tolerated the procedure well. He states that his weakness and numbness/tingling are well controlled with TPE sessions, currently occurring every 2 weeks. Still complains of morning stiffness in his knees, however, he states that his pain lessens throughout the course of the day. Weakness and numbness are clinically significantly improved, and the patient can perform his daily activities including ascending and descending stairs. We will attempt to extend the TPE interval to once every 3 weeks, as the maintenance treatment. Next TPE is scheduled to be performed on XXX …” 4 Excerpt from a Therapeutic Apheresis (TA) Procedure Not for a Patient Requiring Red Blood Cell Exchange: “… Date/Time:         TA Procedure:         TA Physician:       TA Nurse: Risks, benefits, and alternatives were discussed, and all questions were answered; written consent was obtained. Timeout performed in the procedure room. Patient prepped in usual fashion. … Procedure performed by XXX in the XXX Procedure Room. Patient tolerated procedure well without complications. I supervised the entire procedure. XXX, MD (or DO); Attending, XXX Clinical Service …” 5 Excerpt from Note for a Patient Receiving Photopheresis with an Incident of Clot Formation: “… This patient with acute myelogenous leukemia (AML), status post peripheral blood stem cell (PBSC) transplant, and now with chronic graft versus host disease (GVHD), is currently receiving photopheresis scheduled for twice a week until further notice. On [date/time], small clot formation was observed on the extracorporeal plate and tubing, likely due to poor flow through port. Procedure was aborted and the patient was informed that his blood, which clotted in the plate (~300 mL), was not able to be returned to him. The patient was satisfied with and understood this decision. At discharge, the patient's blood pressure was 137/85 mmHg, all vital signs were stable (VSS), and he was in no acute distress (NAD). The patient felt fine and ambulated well despite the 300 mL blood loss. Last week his hemoglobin/hematocrit values were 12.2 g/dL and 36.9%, respectively. A bottle of drinking water was also given to the patient for hydration. Considering this occurrence, we have decided to perform heparinization of the patient 30 min prior to each future photopheresis procedure, beginning with the next procedure …”

The Committee also agreed that such coded commentary should not be considered as immutable and the need to modify coded comments, where necessary depending on clinical circumstances, should always be at the forefront of pertinent and informative documentation. Although individual institutions may wish to incorporate elements from Table 2 into their documentation routines, the Committee members recognized that the adoption of such comments did not preclude individual institutions from developing their own lexicons pertinent to their practice environments and that such endeavors should be encouraged. Regardless of whether coded comments are used or not, however, committee members believed certain “Commendable Practices” in medical documentation, including the juxtaposition of the first use of any abbreviations with the words/phrases that they are being substituted for in any narrative and the use of spellcheck and autocorrection programs in note editing, should be followed, and along with fastidious “proof‐editing” of any texts, should be standard practices.

4. Discussion

No statute‐generating entity, nor regulatory agency, or accrediting body has definitively promulgated the required types, extent, and formats needed for documentation of the supervision of the TA care event overseen by physicians. Likewise, neither have any prescripted documentation formats for TA procedures themselves been promoted, although such entities, as well as several professional societies, have identified data elements that should be captured and included in the charting of these interventions [1, 10, 11, 12]. Due to inquiries from ASFA membership over the years as to how documentation could best be accomplished, an internal ASFA committee deliberated and in 2007 created its “Guidelines for Documentation of Therapeutic Apheresis Procedures in the Medical Record by Apheresis Physicians” [1]. This guideline was based upon subject matter experts' opinions as to a reasonable approach regarding adequate documentation to secure Medicare Part B billing for physician services. These discussions and their subsequent articulation were predicated on the practice environment and available technologies at the time and have been referenced and adopted by many non‐ASFA parties. Although the primary driver for the 2007 initiative was related to billing, subsequent discussions over the years highlighted the importance of documentation for purposes other than finance.

Since the original release of ASFA's guidelines for physician documentation, the healthcare landscapes in which TA services are delivered have changed markedly. The adoption and continuing evolution of electronic medical records (EMRs), telemedicine's introduction and rapid expansion, as well as the SARS‐CoV‐2 global pandemic, have all been impactful contributors to 21st century TA practice [13, 14]. Likewise, the increasing recognition, importance, and institution of multidisciplinary integrated teams in the provision of healthcare have also impacted delivery models for TA. As an acknowledgement of these and other changes in healthcare delivery, the ASFA BOD recognized the need to re‐visit its documentation recommendations eventually assigning this initiative to the Society's PAAC to review, provide commentary, and update the original Guidelines document where pertinent (see Table 5 for a summary of key aspects of the revised guidance).

TABLE 5.

Summary of selected key points/themes identified in the ASFA therapeutic apheresis documentation guidance.

Charge received from ASFA Board of Directors (BOD) to its Public Affairs and Advocacy Committee (PAAC) to coordinate a review and update the Society's 2007 guidance for physician documentation related to the oversight of therapeutic apheresis (TA) activities. Major change agents impacting TA documentation identified including the importance of multidisciplinary care teams, the adoption of telemedicine in TA delivery, and the clinical/patient care challenges derived from the SARS‐CoV‐2 pandemic. Strategies for revised/updated documentation formatting practices related to these changes, not only for physicians' involvement, but recognition and inclusion of other members of multidisciplinary care teams participating in TA, were identified. Examples of seven format scenarios: (1) the TA Initial Consultation Note; (2) the TA Nursing Procedural Note; (3) the TA Physician/Staff Multi‐Author Progress Note; (4) the TA Interval Progress Note; (5) the TA Procedure Deferral Note; (6) the TA End of Service/Discharge Summary Note; and (7) the Post‐TA Series Follow‐up Service Note were developed using a TA clinical care map tool to inform format constructions. The value and the use of “Coded Comments/Templates” and inclusion of pertinent medical literature references in the various documentation scenarios were cited as being useful components in TA documentation, education, and enhancing patient care. The expansion of telemedicine into the Apheresis Medicine (AM) discipline (Telapheresis) was highlighted with the emerging and evolving roles of “virtual telapheresis subject matter experts (VTSMEs)” in the TA care event/episode being identified as a potential clinical resource helping to address current and projected physician workforce shortages in AM. Guidance designed to assist AM practices in the development of their own institutional procedural documentation formats and to serve to improve the quality of care delivered to patients undergoing TA procedures by informing standardization of formats for the documentation of TA procedures and for positioning of the AM specialty to meaningfully contribute to the evolving area of hemotherapy biovigilance and AM related “bedside to bench” medical research activities.

In this regard, the PAAC felt that the latest iteration of the various Current Procedural Terminology (CPT) codes related to TA (see Table 3) would best serve as a foundational framework helping to inform documentation design and formatting for facilitating the capture of data elements supporting both the cognitive and personal involvement of physicians in the supervision of TA activities. The Committee felt that the recognition and documentation of particular CPT codes needed to be aligned with the clinical activities being performed by AM physicians for a variety of reasons. These reasons included but were not limited to aiding collaborative collegial communications between professionals in the immediate healthcare setting, enhancing patient safety in TA, as well as with entities engaged in billing and reimbursement activities and in professional specialty networks dedicated to patient safety and biovigilance monitoring of hemotherapies, many of which unfortunately currently lack a dedicated focus on or even acknowledgment of TA interventions.

TABLE 3.

Various current procedural terminology (CPT) codes related to therapeutic apheresis [1, 2].

CPT codes	Description
36511	Therapeutic apheresis for white blood cells
36512	Therapeutic apheresis for red blood cells
36513	Therapeutic apheresis for platelets
36514	Therapeutic apheresis for plasmapheresis
36516	Therapeutic apheresis; with extracorporeal immunoadsorption, selective adsorption or filtration and plasma reinfusion
36522	Photopheresis, extracorporeal
38205	Blood derived hematopoietic progenitor cell harvesting for transplantation per collection; allogeneic
38206	Blood derived hematopoietic progenitor cell harvesting for transplantation per collection; autologous

Note: (1) For more information on billing practices, see Reference [12] or the latest edition of it. (2) For up‐to‐date information refer to the latest edition of the Code of Federal Regulations (CFR). These guidelines do not address the elements required in an “Evaluation and Management” (E&M) note. Apheresis Medicine physicians may also create E&M consultation notes unrelated to therapeutic apheresis procedure notes (see Reference [12] or the latest edition of it).

Additionally, other sources helping to inform documentation design for other types of AMS clinical interactions, may also need to be considered by institutions in their documentation formatting where the provision of these activities occurs [15]. Such examples include guidance from the Centers for Medicare & Medicaid Services (CMS) relating to reimbursement and coding requirements involving residents and fellows in graduate training programs that may be pertinent, especially if attending physicians intend to bill for their services, and in specific specialty recognized consultation coding options, for example, College of American Pathologists (CAP) codes related to a pathologist's involvement in “laboratory consultative services”.

Along with the major focus on clinical care communications between AM practitioners and their non‐AM colleagues in the various documentation settings examined here, documentation related to TA billing and reimbursement and TA documentation contributing to hemotherapy biovigilance activities were also considered. A full discussion of these aspects is beyond the scope of this work, but for the former entity, readers are referred to published literature that is periodically updated by various organizations including ASFA [12]. With respect to the latter, a paucity of literature exists, but the opportunity to develop TA biovigilance monitoring and reporting mechanisms incorporating elements of standardized TA documentation represents an area that could positively impact the historic and current challenges in achieving this end and such efforts should be encouraged [16].

As noted previously, a team‐based approach to health care delivery is the touchstone of 21st century medical practice and the activities of an AMS are excellent examples where such clinical and interprofessional interactions occur routinely. Although clearly not all AMS‐related notes need inclusion of every care‐team participant, the inclusion of at least one documentation format where the pertinent practitioners are listed has value not only for clinical care communications but in other areas such as healthcare quality improvement activities.

In addition, with the evolution and expansion of telemedicine into the AM discipline (telapheresis), the use of TA multi‐author notes also offers recognition of an emerging practice whereby the inclusion of discussions with and involvement of “virtual telapheresis subject matter experts”(VTSMEs) in the TA care event/episode can be documented. VTSMEs represent an important and evolving clinical resource that potentially can help address current and projected physician workforce shortages in AM, as well as being an asset in helping to expand TA activities geographically in currently underserved areas. Similar in concept to “remote intensive care unit specialists” providing consultations with physician and non‐physician staff in remote hospital intensive care unit (ICU) settings, VTSMEs working in tandem with their front‐line, direct patient‐facing “educated colleagues” at remote hospital sites can potentially offer enhancements in access, education, and quality of care oversight in TA delivery models. Alternatively, telapheresis has also been described within a single institution, with AM physicians remotely supervising both evaluation and management, as well as technical procedure activities as proctored by trained AM nurses employed by the same institution. Such telapheresis strategies become even more relevant and valuable in infectious disease pandemic situations in which workforce constrictions/limitations and management of limited personal protective equipment (PPE) assets (e.g., due to increased demands or supply chain disruptions of critical materials) can occur, as was encountered during the COVID‐19 pandemic years.

Yet another facet to the use of a multi‐author note format allows recognition of the efforts and involvement of non‐physician care providers, for example, apheresis nursing specialists, medical technologists, as well as nurse practitioners and physician assistants, who represent an increasing cadre of practitioners focusing their clinical skillsets in the realm of apheresis medicine. Regardless of the degree of participation of other such providers, however, it should be noted that ASFA through its various resources and peer‐reviewed publications, has promoted the concept that regardless of individual practitioner primary specialties, physicians charged with supervising and providing clinical oversight of TA interventions should be recognized as those whose training, experiences, and professional credentials satisfy the medical institution's requirements for ordering and supervising such procedures. Meeting higher professional thresholds with respect to continuing medical education activities and involvement in patient‐oriented quality improvement activities related to TA at the institutions in which these services are offered have also been recognized as important considerations by the Society [2].

The Committee also discussed the inclusion of an area in the clinical notes for pertinent references in the different documentation formats. Though clearly not a requirement, pertinent references in the correct context may provide an objective rationale for a particular course of therapeutic action. Such citations could be of a more general nature, for example, subject reviews and/or the citation of the periodically updated special issue on the clinical applications of TA published by ASFA in the Journal of Clinical Apheresis [9]. Alternatively, literature more narrowly focused, recently published, or a “classical or seminal publication” regarding a certain disease and indication of the role that TA may or may not play in the management of patients with the disorder, could be cited. The use of an annotated bibliographical format was also considered to be of value in this regard. Examples of these various potential reference types are listed in Table 4.

TABLE 4.

Examples of selected medical literature references pertinent to therapeutic apheresis (TA) and disorders associated with its application.

Pertinent Recent/Past Reviews/Book Chapters, etc.: General Connelly‐Smith L, Alquist CR, Aqui NA, et al. Guidelines on the Use of Therapeutic Apheresis in Clinical Practice—Evidence‐Based Approach from the Writing Committee of the American Society for Apheresis: The Ninth Special Issue. J Clin Apher. 2023; 38 (2): 77–278 (or most current edition). Crookston KP., Editor. Therapeutic Apheresis: A Physician's Handbook. 5th edition. AABB/ASFA, Bethesda, Maryland, 2017. pp. 322–340 (or most current edition). Yan, L‐H, Hu, X‐H, Chen, R‐X, et al. Plasmapheresis Compared With Conventional Treatment for Hypertriglyceridemia‐Induced Acute Pancreatitis: A Systematic Review and Meta‐Analysis. J Clin Apher. 2023; 38 (1): 4–15. doi: 10.1002/jca.22018. Various Authors. AABB Technical Manual chapter on “Therapeutic Apheresis” (current and/or prior editions). AABB Press. Various Authors. AABB Transfusion Reactions chapter on “Complications on Therapeutic Apheresis” (current and/or prior editions). AABB Press. Pertinent Recent/Past Primary/Secondary Literature: Various Disorders Alquist, C.R., Szczepiorkowski, Z.M. and Dunbar, N. (2017), Babesia Parasitemia Rebound After Red Blood Cell Exchange. J. Clin. Apheresis. 32: 276–278. https://doi.org/10.1002/jca.21492. Harris ES, Meiselman HJ, Moriarty PM, Metzger A, Malkovsky M. Therapeutic Plasma Exchange for the Treatment of Systemic Sclerosis: A Comprehensive Review and Analysis. J Scleroderma Relat Disord. 2018 Jun; 3 (2): 132–152. doi: 10.1177/2397198318758606. Epub 2018 Mar 9. PMID: 35382237; PMCID: PMC8892860. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8892860/. Pertinent Frequently Cited/“Classic” References: Various Disorders Rock GA, Shumak KH, Buskard NA, et al. Comparison of Plasma Exchange and Plasma Infusion in the Treatment of Thrombotic Thrombocytopenic Purpura. N Engl J Med. 1991: 325: 393–397. Dau PC, Lindstrom JM, Cassel CK, et al. Plasmapheresis and Immunosuppressive Drug Therapy in Myasthenia Gravis. N Engl J Med. 1977; 297: 1134–1140. Owen HG, Brecher ME. Atypical Reactions Associated With Use of Angiotensin‐Converting Enzymes Inhibitors and Apheresis. Transfusion. 1994; 34: 891–894. Pertinent Specific Disease‐Focused Literature: Sickle Cell Disease (SCD) US Department of Health and Human Services, National Heart, Lung, and Blood Institute. Evidence‐Based Management of Sickle Cell Disease, Expert Panel Report, 2014. Sarode, R, Ballas, SK, Garcia, A, et al. Red Blood Cell Exchange: 2015 American Society for Apheresis Consensus Conference on the Management of Patients With Sickle Cell Disease. J Clin Apher. 2017; 32: 342–367. https://doi.org/10.1002/jca.21511. Yawn BP, Buchanan GR, Afenyi‐Annan AN, Ballas SK, Hassell KL, James AH, Jordan L, Lanzkron SM, Lottenberg R, Savage WJ, Tanabe PJ, Ware RE, Murad MH, Goldsmith JC, Ortiz E, Fulwood R, Horton A, John‐Sowah J. Management of Sickle Cell Disease: Summary of the 2014 Evidence‐Based Report by Expert Panel Members. JAMA. 2014 Sep 10; 312 (10): 1033–1048. doi: 10.1001/jama.2014.10517. Erratum in: JAMA. 2014 Nov 12; 312 (18): 1932. Erratum in: JAMA. 2015 Feb 17; 313 (7): 729. PMID: 25203083. DeBaun MR, Jordan LC, Kink AA, et al. American Society of Hematology 2020 Guidelines for Sickle Cell Disease: Prevention, Diagnosis, and Treatment of Cerebrovascular Disease in Children and Adults. Blood Advances. 2020; 4 (8): 1554–1588. doi: 10.1182/bloodadvances.2019001142. Wu DW, Jacobson J, Lifshitz M, et al. A Retrospective Study for Association Between Post‐Transfusion Hemoglobin S Level and Pre‐Transfusion Hemoglobin S Level at the Next Scheduled Transfusion. J Clin Apher. 2023; 1–11. doi: 10.1002/jca.22056. Pertinent Electronic Format Resources: American Society for Apheresis (ASFA) Website: https://www.apheresis.org/. Association for the Advancement of Blood and Biotherapeutics (AABB) Website: https://www.apheresis.org/. College of American Pathologists (CAP) Website: https://www.cap.org/. US Food and Drug Administration (FDA) Website: https://www.fda.gov/. Foundation for the Accreditation of Cellular Therapy (FACT) Website: https://factglobal.org/. Fridey JL and Kaplan AA. Therapeutic Apheresis (Plasma Exchange or Cytapheresis): Indications and Technology. UpToDate. Current version. https://www.uptodate.com/contents/therapeutic‐apheresis‐plasma‐exchange‐or‐cytapheresis‐indications‐and‐technology?source=autocomplete&index=0~4&search=Therapeutic%20Apheresis. Manis JP. Overview of Therapeutic Monoclonal Antibodies. UpToDate. Current version. https://www.uptodate.com/contents/overview‐of‐therapeutic‐monoclonal‐antibodies?search=therapeutic%20apheresis%20%20patient%20information&source=search_result&selectedTitle=10~150&usage_type=default&display_rank=10. Clinical Policy Bulletin on Plasmapheresis/Plasma Exchange/Therapeutic Apheresis (latest version). Aetna Inc. https://www.aetna.com/cpb/medical/data/200_299/0285.html. Pertinent Electronic Format Resources for Patients: See Websites for American Society for Apheresis (ASFA), other professional societies involved with therapeutic apheresis and biotherapies, and/or pertinent patient focused disease‐specific organizations.

Although the decision to include references is an individual practitioner's prerogative, the inclusion of pertinent references may be of particular value in at least two of the note formats, that is, TA Initial Consultation Note and TA Physician/Staff Multi‐Author Progress Note. The provision of references in either note is reasonable from several perspectives including but not limited to supporting a differential diagnosis assessment and/or a decision to perform or not perform the TA intervention and the strategies to be applied in such interventions where applicable. Members also highlighted the teaching/educational value of such inclusion, not just for AMS resident staff, but also referring physicians and other non‐AMS colleagues involved in the care of the patient.

Additional benefits of using such an approach were also identified including the value that other entities, for example, hospital coders, QI and risk management staff, and third‐party payers, could gain from seeing such information. The use of hyper‐linked citations was discussed and considered to be a positive aspect, but it was noted that the decision to potentially use this tool likely would vary across institutional lines depending on the institution's IT policies and abilities for placement of such links into a patient's EMR.

For completeness of discussion, the group members noted that documentation protocols will likely vary depending on the mode of AMS delivery. Specifically for example, AMS provided in the context of a community mobile apheresis program [17], by necessity generates two sets of documents, that is, documents derived from the organization dispatching the equipment and operators and documentation from the institution where the patient is receiving care. The team in this case is cross‐institutional in composition. In such a contractually bounded relationship, the medical director of the mobile apheresis service is typically the apheresis medicine expert while the requesting physician is typically the educated colleague. Based on preceding collegial consultative discussions between these individuals, the subsequent generation of the initial TA consultation note, incorporating the appropriateness and approach of a TA intervention, represents both a guidance document for use by apheresis nursing service personnel as well as fulfilling any documentary expectations contained within the pertinent contracted agreements between the two healthcare entities.

Optimally, the essence of the consultation discussion is incorporated both into the requesting physician's documentation justifying the procedure following the principles articulated earlier in this manuscript and into the mobile apheresis medicine service's consultation note justifying the dispatch of resources. Separately, the TA nursing procedural note is necessary for the specific patient care event and for billing purposes and thus must be included in the patient's medical record. Given the very team‐oriented nature of this AM practice modality, an interactive TA physician/staff multi‐author progress note incorporating all elements is an ideal format to maintain care coordination throughout the TA care episode. These documentation approaches are also valuable for quality assurance activities and help ensure that the contracted provider remains appropriately engaged in the care of the patient [18]. Although the modality of apheresis medicine services may vary in the mobile setting, best practice principles remain identical to those identified for non‐mobile AMS operations.

An emerging area of importance also recognized by the Committee centered around TA documentation into an institution's Patient Health Records Portal System (PHRPS). Although the degree of data and information that may be included in such systems varies institutionally, the inclusion of all the previously mentioned types of documentation would seem likely unnecessary since such “documentation overload” could potentially cause confusion and undue concern for many individuals not familiar with a specialty's communication needs among its practitioners. As this is an evolving area, however, not only due to technological advances but also to legislative and regulatory mandates, careful monitoring of changes related to it needs to occur.

In this regard, directives contained within the 21st Century Cures Act (Cures Act), passed into law in 2016 with subsequent clarifications from The Office of the National Coordinator for Health Information Technology (ONC), are of note [19]. As of October 6, 2022, the ONC's Cures Act Final Rule supports access, exchange, and use of electronic health information (EHI) which will allow individuals, via standardized application programming interfaces (APIs), to securely and easily view their EHI. Provisions included in the rule require that patients, at no cost, can electronically access all their structured and/or unstructured EHI. In its essence, the Final Rule allows patients to view their entire electronic medical record, of which TA documentation would be a part, in an unencumbered manner.

At the time of the Committee's deliberations, detailed information on how institutions should implement strategies to accomplish the Final Rule's expectations has not been offered. Nevertheless, regardless of how such details will eventually manifest, AMS practitioners should consider developing a pertinent summary document that is specifically patient focused for inclusion into their PHRPS. In such a document(s), inclusion of pertinent clinical/procedural data along with patient educational/instructive materials, especially with respect to the development of potentially related adverse sequalae post‐TA and the communication of any such issues by the patient to AMS staff, along with next visit follow‐up appointment information, would seem reasonable.

Documentation of other types of AMS activities was also acknowledged by the group and noted to be of importance, for example, informed consent documents, patient order sets, quality monitoring checklists of AMS activities, and so forth, but were deferred from study by the group with the expectation of their subsequent consideration by the Society at a future time. Similarly, the rapidly evolving areas and uses of artificial intelligence (AI) technologies, especially generative pre‐trained transformers (GPTs), were identified as important issues potentially pertinent to AM documentation and analytics with group members in agreement that discussions and events related to them should merit close watching and likely future commentary by the Society [20, 21, 22, 23, 24, 25, 26, 27, 28].

Finally, in addition to the previously noted limitations of the group's efforts, it was noted that the focus and reliance on the latest iteration of the Current Procedural Terminology (CPT) codes related to TA in informing the documentation designs, by default, excluded certain TA modalities, for example, those not currently approved by the United States (US) Food and Drug Administration (FDA) or not currently available in the United States. If, and when such technologies become available in the United States, as well as for international colleagues who may be currently using them, expectations of the group's members were that a similar deliberative strategy for pertinent documentation development related to those TA technologies would follow closely the positions articulated here.

In summary (see Table 5), TA care interventions are best provided as consultative services to an individual patient. Supervising physicians are responsible for documenting their supervision/oversight of the apheresis procedure in the medical record according to the standards of their institutions. This Guidance is intended to assist medical establishments in the development of their own institutional procedural documentation formats. These guide points also suggest documentation attributes that help support the use of the various CPT codes used for billing for physician services related to TA interventions as well as for general educational purposes related to TA. Of greater importance, however, they also serve to improve the quality of care delivered to patients undergoing TA procedures by informing standardization of formats for the documentation of TA procedures and for positioning of the AM specialty to meaningfully contribute to the evolving area of hemotherapy biovigilance and AM related “bedside to bench” medical research activities. Finally, the use of coded comments and structured note templates may be of utility in TA procedure documentation by streamlining AM practitioners' charting and helping with “natural language searching” of an institution's electronic assets for clinical research and biovigilance monitoring activities.

Funding

The authors have nothing to report.

Disclosure

It is the intent of the American Society for Apheresis (ASFA), the authors, and the editors to provide current and accurate information to the reader. Furthermore, ASFA, the authors, and the editors disclaim any responsibility for any adverse event as a consequence, directly or indirectly, from the application of any suggested treatment, protocol, and/or procedure. Nor will ASFA, the authors, or the editors accept responsibility for any undetected errors or misunderstanding of any information contained in this document. The apheresis principles, policies, and procedures described in this document must be prescribed by a qualified physician and administered under the supervision of a qualified physician (as outlined in various pertinent ASFA publications) and in accordance with applicable Federal, State, and Local regulatory agency requirements.

Conflicts of Interest

The authors declare no conflicts of interest.

Supporting information

Data S1: jca70092‐sup‐0001‐Supplemental File 1.docx.

Data S2: jca70092‐sup‐0002‐Supplemental File 2.docx.

Data S3: jca70092‐sup‐0003‐Supplemental File 3.docx.

Data S4: jca70092‐sup‐0004‐Supplemental File 4.docx.

Data S5: jca70092‐sup‐0005‐Supplemental File 5.docx.

Data S6: jca70092‐sup‐0006‐Supplemental File 6.docx.

Data S7: jca70092‐sup‐0007‐Supplemental File 7.docx.

Data S8: jca70092‐sup‐0008‐Supplemental File 8.docx.

Data S9: jca70092‐sup‐0009‐Supplemental File 9.docx.

Data Availability Statement

Data sharing not applicable to this article as no datasets were generated or analyzed during the current study.