Synergy Hematology Oncology

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 11/20/2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful [proficiency testing] participation; and D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and AAB-Medical Laboratory Evaluation records (2025-2 and 2025-3), the laboratory failed to successfully participate in a proficiency testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the analyte IG M, resultting in unsuccessful performance. See D2084. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and AAB-Medical Laboratory Evaluation report, the laboratory failed to achieve satisfactory performances for two of three consecutive events (2025-2 and 2025-3) for the analyte Ig M: The finding include: IgM 40% - 2025 second testing event; IgM 60% - 2025 third testing event; A review of the 2022 & 2023 scores from AAB-Medical Laboratory Evaluation confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and AAB- Medical Laboratory Evaluation records for 2025-2 and 2025-3 events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and AAB- Medical Laboratory Evaluation records for 2025-2 and 2025-3 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2084. -- 2 of 2 --

Summary Statement of Deficiencies D2066 SYPHILIS SEROLOGY CFR(s): 493.835(a) (a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on the surveyor's review of the American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records and interviews with the technical consultant (TC) and the testing personnel (TP); it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent for the first event of 2022 (Q1-2022). The findings include: 1. The laboratory performed Rapid Plasma Reagin (RPR) using ASI card test kit and enrolled its proficiency testing program with AAB-MLE. 2. The laboratory attained an overall unsatisfactory performance of 60% for RPR test in the Q1-2022 event. 3. The TC and TP affirmed in interviews on June 25, 2025 at approximately 10:00 a. m. that the laboratory attained the unsatisfatory scores as mentioned in statement #2. The quality and reliability of patient tests reported cannot be assured. 4. According to the testing declaration form submitted at the time of survey, the laboratory performed and reported approximately 461 RPR tests including the time the laboratory received the unsatisfactory scores. . D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on surveyor's review of the American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records, ten randomly chosen patient reports, and interviews with the technical consultant (TC) and testing personnel (TP); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for high sensitive C-Reactice protein (hs-CRP) and Rheumatoid Factor (RF) analytes. The findings include: 1. The laboratory was enrolled with AAB-MLE PT program and obtained unsatisfactory scores for RF during the first event of 2023 (Q1-2023) and hs-CRP on the first event of 2025 (Q1- 2025). The result as follows: a. RF analyte on Q1-2023, Overall score: 60% Specimen Reported Expected 1 *1 3.0 - 11.0 2 121 85.0 - 159.0 3 121 85.0 - 158.0 4 67 46.0 - 86.0 5 *1 2.0 - 10.0 b. hs-CRP analyte on Q1-2025, Overall score: 20% Specimen Reported Expected 1 0.07 0.0 - 1.43 2 *0.43 3.15 - 5.86 3 *0.71 5.09 - 9.45 4 *0.21 1.12 - 3.12 5 *0.7 5.09 - 9.46 Legend: * = unsatisfactory score 2. The TC and TP affirmed on June 25, 2025, at approximately 10:00 a.m. that the laboratory received the unsatisfactory PT scores of for RF and hs-CRP as mentioned in statement#1. 3. The quality and reliability of patient results reported cannot be assured during the time when the laboratory obtained the unsatisfactory scores. 4. According to the testing declaration form submitted at the time of survey, the laboratory tested and reported approximately 2,914 hs-CRP and 404 RF patient samples annually for the subspecialty of General Immunology. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policy/procedure, American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records, and interviews with the technical consultant (TC) and testing personnel (TP), it was determined that the laboratory failed to attain at least 80 percent of the acceptable score in Routine Chemistry for the Iron analyte in the second event of 2024 (Q2-2024). The findings include: 1. The surveyor reviewed the PT records for Q2-2024, wherein AAB-MLE reported an unsatisfactory score of 60%for the Iron analyte. 2. The TC and TP affirmed by interviews on June 25, 2025, at approximately 10:00 a.m. that the laboratory obtained the PT unsatisfactory scores mentioned in statement #1. Thus, the accuracy and reliability of patient test reported cannot be determined. 3. According to the testing declaration form submitted on the day of the survey, the laboratory performed approximately 2,040 Iron patient test samples including the time the laboratory received an unsatisfactory proficiency testing score. D2098 ENDOCRINOLOGY CFR(s): 493.843(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policy/procedure, American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records, and interviews with the technical consultant (TC) and testing personnel (TP); it was determined that the laboratory failed to attain at least 80 percent of the acceptable score in Endocrinology for the Thyroglobulin analyte in the first event of 2025 (Q1-2025). The findings include: 1. The surveyor reviewed the PT records for Q1-2025, where API reported an unsatisfactory score. The results were as follows: a. Thyroglobulin PT Q1-2025 Overall score: 0% Specimen Reported Expected 1 *3.2 82.2 - 115.0 2 *7.1 45.3 - 57.1 3 *4.9 64.1 - 86.5 4 *8.8 23.6 - 31.3 5 *12.6 2.7 - 4.7 Legends: * = unsatisfactory score reported 2. The TC and TP affirmed by interviews on June 25, 2025, at approximately 10:00 a.m. that the laboratory obtained the PT unsatisfactory score mentioned in statement #1. 3. According to the laboratory's testing declaration submitted on the day of the survey, the laboratory performed approximately 201 Thyroglobulin patient test samples during the time the laboratory received an unsatisfactory proficiency testing score. Thus, the accuracy and reliability of patient test reports cannot be determined. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. The technical consultant is not required to be onsite at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide consultation, as specified in paragraph (a) of this section. This STANDARD is not met as evidenced by: Based on the surveyor's review of the proficiency testing results from the American Association of Bioanalysts - Medical Laboratory Evaluation, and interviews with the technical consultant (TC) and testing personnel on June 12, 2025; this deficient practice is cited due to failure of the TC to provide technical and scientific oversight of the laboratory. The findings include: 1. Unsatisfactory proficiency testing score for SYphilis Serology. See D2066. 2. Unsatisfactory proficiency testing score for General Immunology. See D2075. 3. Unsatisfactory proficiency testing score for Routine Chemistry. See D2087. 4. Unsatisfactory proficiency testing score for Endocrinology. See D2098. -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing (PT) results from AAB, and interview with the laboratory technical consultant on March 30, 2023, at 2:30 pm, the laboratory failed to successfully participate in the proficiency testing program for the Cr test. The findings include: 1. The laboratory participated in the AAB PT testing program for the specialty of chemistry in the year 2021. However, it received an unsatisfactory score of 60% at the Q1 and Q3 events for Cr test, resulted in an unsuccessful PT participation. Therefore, the accuracy of the patients' test results rendered by the laboratory during that time cannot be assured. 2. The laboratory technical consultant on March 30, 2023, at 2:30 pm, affirmed that the laboratory did Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- not receive a satisfactory score for the Cr test at the Q1 and Q3 events of PT in 2021. 3. The laboratory's testing declaration form, signed by the laboratory director on 3/27 /2023, stated that the laboratory performs approximately 8,586 Cr tests, annually. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing (PT) results from AAB, and interview with the laboratory technical consultant on March 30, 2023, at 2:30 pm, the laboratory failed to achieve satisfactory performance for the Cr test in two consecutive testing events. The findings include: 1. The laboratory participated in AAB PT testing program for the specialty of chemistry in the year 2021. However, it received an unsatisfactory score of 60% at both Q1 and Q3 events for Cr test that resulted in an unsatisfactory analyte performance. Laboratory's failure to achieve satisfactory performance for the same analyte in two consecutive events resulted in an unsuccessful PT performance. Therefore, the accuracy of the patients' test results rendered by the laboratory during that time cannot be assured. 2. The laboratory technical consultant on March 30, 2023, at 2:30 pm, affirmed that the laboratory did not receive a satisfactory score for the Cr test at the Q1 and Q3 events of PT in 2021. 3. The laboratory's testing declaration form, signed by the laboratory director on 3/27 /2023, stated that the laboratory performs approximately 8,586 Cr tests, annually. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's specimen records, and interview with the laboratory technical consultant on March 30, 2023, at 2:20 pm, the laboratory failed to document the date and time it received specimens. The findings include: 1. The laboratory collected specimens at 2 locations in 2 different cities. At the 1st location, laboratory performed CBC test and send out the sample to the 2nd location for the other tests. However, the 2nd location did not document the date and time it received the specimen for testing. Instead, the laboratory (2nd location) used the 1st location's received date on its report. On the day of the inspection, 3 samples (Accn# 230329015, 230330001, 230329039) were found test pending for which specimens were collected at the 1st location and not received by the laboratory. Therefore, the sample integrity and reported results can not be assured since the received date on the report is not accurate and may have harmed patients. 2. The laboratory technical consultant on March 30, 2023, at 2:20 pm, affirmed that the laboratory did not document the date it received the specimen but used the collection date as received date on the report. 3. The laboratory's testing declaration form, signed by the laboratory director on 3/27/2023, stated that the laboratory performs approximately 95,669 tests in chemistry, annually. -- 2 of 5 -- D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy and procedure, CBC test records, and interview with the laboratory technical consultant and testing person's assistant on March 30, 2023, at 1:55 pm, the laboratory personnel failed to follow laboratory's policy and procedure to process the sample that had a critical value. The findings include: 1. The laboratory received a sample on March 29, 2023, at 11:47 am and ran CBC test on the sample using Sysmex XN automated instrument. The instrument print out showed PLT result was critical low. According to the laboratory's policy and procedure the critical results should have been confirmed and notified immediately to the physician. However, as of 1:55 pm, March 30, 2023, the patient results were still pending in the laboratory information system. Furthermore, the testing person's assistant notified the results to the physician without confirming the critical results. Therefore, the validity of the patients' test results rendered by the laboratory cannot be assured and may have harmed patient. 2. The laboratory technical consultant on March 30, 2023, at 1:55 pm, affirmed that the laboratory personnel did not follow its procedure. 3. The laboratory's testing declaration form, signed by the laboratory director on 3/27/2023, stated that the laboratory performs approximately 66,834 CBC tests, annually. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing (PT) and patient sample testing records, and interview with the laboratory technical consultant and testing person's assistant during an onsite survey of the laboratory on March 30, 2023, at 1:55 pm, and the severity and the number of deficiencies found and cited herein, it was determined that the laboratory director failed to provide effective direction over the operation of the laboratory, hence the Condition: Laboratories performing moderate complexity testing; laboratory director was not met. The laboratory director's failure to provide direction over the laboratory operation has a consequence of potential erroneous test result reporting and patient harm. The findings include: 1. The laboratory director failed to assure compliance with the applicable regulations. (See D6004) 2. The laboratory director failed to ensure the maintenance of an acceptable levels of analytical performance for the Cr tests. (See D6023) 3. The laboratory director failed to ensure that the laboratory personnel are performing the test methods as required for accurate and reliable results. (See D6014) D6004 LABORATORY DIRECTOR RESPONSIBILITIES -- 3 of 5 -- CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing (PT) and patient sample testing records, and interview with the laboratory technical consultant on March 30, 2023, at 2:20 pm, the laboratory director failed to assure laboratory's compliance with the applicable regulations and potentially harm patients. The findings include: See D2016, D2096, D5313, D5401 and D6070. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing (PT) results from AAB, and interview with the laboratory technical consultant on February 15, 2023, at 11:45 am, the laboratory failed to achieve satisfactory performance for the WBC differential test in two consecutive testing events and attain a score of at least 80 percent of acceptable responses for the bicarbonate analyte at Q3 testing event in 2022. The findings include: See D2087 and D2130. D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing (PT) results from AAB, and interview with the laboratory technical consultant on March 30, 2023, at 2:30 pm, -- 4 of 5 -- the laboratory failed to achieve satisfactory performance for the Cr test in two out of three consecutive testing events and attain a score of at least 80 percent of acceptable responses for the Cr analyte at Q1 and Q3 testing events in 2021. The findings include: See D2016 and D2096. D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) Each individual performing moderate complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy and procedure, CBC test records, and interview with the laboratory technical consultant and testing person's assistant on March 30, 2023, at 1:55 pm, the laboratory testing person #1 failed to follow the laboratory's policy and procedure to test and report patient's critical results. The findings include: 1. The laboratory received a sample on March 29, 2023, at 11:47 am and ran CBC test on the sample using Sysmex XN automated instrument. The instrument print out showed PLT result was critical low. According to the laboratory's policy and procedure the critical results should have been confirmed and notified immediately to the physician. However, as of 1:55 pm, March 30, 2023, the patient results were still pending in the laboratory information system. Furthermore, the testing person's assistant notified the results to the physician without confirming the critical results. Therefore, the validity of the patients' test results rendered by the laboratory cannot be assured and may have harmed patient. 2. The laboratory technical consultant on March 30, 2023, at 1:55 pm, affirmed that the laboratory personnel did not follow its procedure. 3. The laboratory's testing declaration form, signed by the laboratory director on 3/27/2023, stated that the laboratory performs approximately 66,834 CBC tests, annually. -- 5 of 5 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of hematology constituting unsuccessful PT performance. (See D2130) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- D2077 GENERAL IMMUNOLOGY CFR(s): 493.837(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on reviews of proficiency testing reports from CMS (report 155D, Individual Laboratory Profile) and AAB (American Association of Bioanalysts) for IgA, IgG, and IgM tests performed on the Beckman AU 480 analyzer, ten (10) randomly selected patients test records from 0105/2019 to 10/02/2020 and an interview with the technical superior (TS), it was determined that the laboratory failed to participate in testing event Q3-2013, constituting unsatisfactory performance resulting in the score of 0%. The findings include: 1. For AAB Q3-2019, CMS reported an unsatisfactory score of 0% for the specialty of general immunology IgA, IgG and IgM, and also failed to follow the laboratory policies and procedure manual, under Proficiency Testing Policy, "Upon receiving PT samples, laboratory will': Items 1 through 8 were not followed. 2. The technical affirmed 10/21/2020 1:20 p. m. (survey date) that the laboratory failed to participate in the AAB Q3 event of 2019 for specialty of general immunology. 3. Based on the laboratory's testing declaration of 10/20/2020, the laboratory reported approximately 1,245 results for general immunology testing (IgA, IgG, IgM). D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the CMS AAB (American Association OF Bioanalysts) proficiency testing (PT) report 0096D (CLIA Application and Survey Summary) for 2019 and 2020 test results, ten (10) randomly selected patients test records from 0105 /2019 to 10/02/2020 and an interview with the laboratory technical supervisor; it was determined that the laboratory failed to participate in the proficiency testing event for Routine Chemistry third event (Q3-2019) for multiple analytes resulting in a 0%score. The findings included: 1. The laboratory received a score of 0% for AAB Q3-2019 PT -- 2 of 5 -- event (nonparticipation) for routine chemistry analytes: ALT (SGPT), albumin, alkaline phosphatase, amylase, AST (SGOT), total bilirubin, total calcium, chloride (CL), total cholesterol, HDL, total CK, creatinine, glucose (non-waived), total iron, LDH, magnesium (MG), potassium, sodium (K), total protein (TP), triglycerides, BUN, and uric acid, and also failed to follow the laboratory policies and procedure manual, under Proficiency Testing Policy, "Upon receiving PT samples, laboratory will': Items 1 through 8 were not followed. 2. The technical supervisor affirmed 10/21 /2020 at 1:20 p. m. (Survey Date) that an AAB Q3-2019 PT 0% score was received for routine chemistry. 3. Based on the laboratory's annual testing declaration submitted 10/20/2020 the laboratory analyzed and reported approximately 179,000 Routine Chemistry tests. D2100 ENDOCRINOLOGY CFR(s): 493.843(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the CMS AAB (American Association OF Bioanalysts) proficiency testing (PT) report 0096D (CLIA Application and Survey Summary) for 2019 and 2020 test results, ten (10) randomly selected patients test records from 0105 /2019 to 10/02/2020 and an interview with the laboratory technical supervisor (TS); it was determined that the laboratory failed to participate in the proficiency testing event for Routine Chemistry third event (Q3-2019) for multiple analytes resulting in a 0% score. The findings included: 1. The laboratory received a score of 0% in the subspecialty endocrinology for the following analytes: cortisol, estradiol, Free thyroxine (T4), FSH, LH, progesterone, prolactin, testosterone, thyroid-stimulating hormone (TSH), thyroxine (T4), triiodothyronine (T-3) T3 uptake, and also failed to follow the laboratory policies and procedure manual, under Proficiency Testing Policy, "Upon receiving PT samples, laboratory will': Items 1 through 8 were not followed. The technical supervisor affirmed 10/21/2020 at 1:20 p. m. (Survey Date) that an AAB Q3-2019 PT 0% score was received for endocrinology. 2. Based on the laboratory's annual testing declaration submitted 10/20/2020 the laboratory analyzed and reported approximately 7,014 endocrinology test results reported... D2111 TOXICOLOGY CFR(s): 493.845(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of -- 3 of 5 -- patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the CMS AAB (American Association OF Bioanalysts) proficiency testing (PT) report 0096D (CLIA Application and Survey Summary) for 2019 and 2020 test results, ten (10) randomly selected patients test records from 0105 /2019 to 10/02/2020 and an interview with the laboratory technical supervisor; it was determined that the laboratory failed to participate in the proficiency testing event for Routine Chemistry third event (Q3-2019) for multiple analytes resulting in a 0%score. The findings included: 1. The laboratory received a score of 0% for AAB Q3-2019 PT event (nonparticipation) for toxicology (therapeutic drugs) analytes: phenytoin and Valproic acid, and also failed to follow the laboratory policies and procedure manual, under Proficiency Testing Policy, "Upon receiving PT samples, laboratory will': Items 1 through 8 were not followed. 2. The technical supervisor affirmed 10/21/2020 at 1: 20 p. m. (Survey Date) that an AAB Q3-2019 PT 0% score was received for toxicology. c. Based on the laboratory's annual testing declaration submitted 10/20 /2020 the laboratory analyzed and reported approximate number of therapeutic drugs not listed. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on reviews of proficiency testing reports from CMS (report 0153D) and AAB (American Association of Bioanalysts) proficiency report, ten (10) randomly selected patients test records from 0105/2019 to 10/02/2020 and an interview with the technical superior (TS) ), it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for hematology analytes (WBC Differential, RBC, Hematocrit (HCT), Hemoglobin (HGB), white blood cell count (WBC) and Platelets (PLTS). The findings include: 1. Based on CMS PT records (CMS CASPER Report 0153D), it was determined that the laboratory failed to achieve satisfactory performance for the same analytes or tests in two out of three consecutive PT events for the analytes, WBC Differential, RBC, HCT, HGB, WBC and PLTS, resulting in a subsequent unsuccessful performance performed on the Systemax analyzer, and also failed to follow the laboratory policies and procedure manual, under Proficiency Testing Policy, "Upon receiving PT samples, laboratory will': Items 1 through 8 were not followed. The findings include: AAB Q3-2019 AAB Q2-2020 0% 0% 2. The technical superior affirmed on 10/21/2020 1:20 p. m. (survey date) that laboratory failed two consecutive testing events of unsuccessful performance for WBC Differential, RBC, HCT, HGB, WBC and PLTS for the AAB PT events of Q3-2019 and Q2-2020. 3. The laboratory's testing declaration form, signed by the laboratory Director on 10/20/2020, stated that the laboratory performed 31,340 automated CBCD tests annually. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT -- 4 of 5 -- CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on the surveyor's observation, examination of laboratory reagents, ten (10) randomly selected patient test reports covering the period from 01/03/ 2019 to 10/ 21 /2020, and interview with the laboratory technical supervisor (TS), it was determined that the laboratory failed not to use reagents when they have exceeded their expiration date. The findings included: 1. On the day of inspection, 10/2/2020 at approximately 11:30 a.m. the examiner found in the phlebotomy basket expired vacutainer test tubes EDTA Lot 9065819, expiration date 2018-18-31). 2. The technical superior affirmed on 10/21/2020 at 1:20 p.m. that the vacutainer test tubes had exceeded their expiration dates and the quality and reliability of the patients test results were in question. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of CMS PT records and the American Association of Bioanalysts (AAB) proficiency testing documents, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H of this part. The findings included: 1. For the analytes: WBC Differential Count, RBC, HCT, HGB, WBC and PLTS Q2-2020 the laboratory repeatedly failed to achieve satisfactory performance for the same analytes or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (See D2016 and D2130) -- 5 of 5 --

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review third quarter (Q3-2016), second quarter (Q2-2017), and third quarter (Q3-2017), of the American Association of Bioanalysts (AAB) proficiency testing records, random patient sampling test results and interview with the testing personnel, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Urea Nitrogen (BUN), Cholesterol, Total and Cholesterol, HDL analytes. The findings included: a. AAB reported the following unsatisfactory proficiency testing scores. Analyte: Score: Event/Year: BUN 60% Q3-2016 Chol, HDL 60% Q2-2017 Chol, Total 40% Q3-2017 b. For eleven (11) out of eleven (11) random patient sampling test results reviewed covering period from 2/1/2016 to 3/30 /2018, the laboratory analyzed and reported Routine Chemistry tests during the time proficiency testing results were unsatisfactory. c. The testing personnel affirmed (4/2 /2018, 12:30), that the laboratory received the above unsatisfactory proficiency testing scores for the above analytes. D2109 TOXICOLOGY CFR(s): 493.845(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review first quarter (Q1-2017) of the American Association of Bioanalysts Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- (AAB) proficiency testing records, and interview with the testing personnel, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Phenytoin and Valproic Acid analytes. The findings included: a. AAB reported the following unsatisfactory proficiency testing scores. Analyte: Score: Event/Year: Phenytoin 60% Q1-2017 Valproic Acid 60% Q1-2017 b. Based on the laboratory's annual testing volume submitted for 2017-2018, the laboratory analyzed and reported 27 Phenytoin and 196 Valproic Acid tests. c. The testing personnel affirmed (4/2/2018, 12:30), that the laboratory received the above unsatisfactory proficiency testing scores. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review first quarter (Q1-2016), second quarter (Q2-2016), third quarter (Q3- 2016), and third quarter (Q3-2017) of the American Association of Bioanalyts (AAB) proficiency testing records and interview with the testing personnel, it was determined that the laboratory failed to verify the accuracy of the above analytes with an artificial score of 100%. The findings included: Q1-2016 a. AAB reported the following artificial 100% proficiency testing scores. Analyte: Value Acceptable Reported: Range: Lipase 1# 11 15-28 Lipase 2# 6 12-22 Folate 2? >24 9.8-18.2 Note: True Lipase score should have been 60%. True Folate score should have been 50% Q2- 2016 Analyte: Value Acceptable Reported: Range: Bili, Direct 2# 5.1 2.9-4.4 Lipase 1# 52 27-50 Lipase 5# 60 29-54 Note: True Bili, Direct score should have been 50% True Lipase score should have been 60% Q3-2016 Analyte: Value Acceptable Reported: Range: Beta-2 Macroglob 1# 15 1.12-2.08 Beta-2 Macroglob 2# 10 0.75- 1.4 Bili, Direct 1# 2.2 1-1.8 Bili, Direct 2# 6.9 3.7-5.5 Note: True Beta-2- Macroglobulin should have been 0%. True Bili, Direct score should have been 0%. Q3-2017 Analyte: Value Acceptable Reported: Range: Bili, Direct 1# 1.8 0.7-1.5 Bili, Direct 2# 6.8 3.7-5.6 Myoglo 2? 653 255-474 Beta-2- Microglo 1? 0 1.51-2.8 Note: True Bili, Direct score should have been 0%. True Myoglobin, 2v score should have been 50% True Beta-2-Microglobulin score should have been 50% b. Based on the AAB proficiency testing footnotes, "# sign = This method was not graded due to an insufficient number of peer respondents. No appropriate default grouping was available. the listed range should provide a reasonable guide to your performance. However, exercise caution in evaluating your results." Based on the AAB proficiency footnotes, " ?= This score may not truly evaluate performance for this specimen which was not graded because of a lack of participant consensus." c. For eleven (11) out of eleven (11) random patient sampling test results reviewed covering period from 2/1 /2016 to 3/30/2018, the laboratory analyzed and reported the above unsatisfactory proficiency testing results and yet the laboratory has no documentation of