Capital Health Hematology/Oncology

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 an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve a score of 80% or more for Hematology tests performed with the American Academy of Family Physicians (AAFP). The finding includes: 1) The laboratory scored 0% for Lymphocyte, Monocyte/Mixed, White Blood Cell Count, Lymphocyte, Ganulocyte, Red Blood Cell Count, Hemoglobin, Hematocrit, and Platelet count for events B and C -2021 with the AAFP. D2130 HEMATOLOGY 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 -- 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 an office review of the proficecny testing provider reports and CASPER reports 153 and 155 and Proficiency Testing (PT), the laboratory failed to achieve a score of 80% or more in two out of three event for for Hematology tests performed with American Academy of Family Physicians (AAFP). The finding includes: 1) The laboratory scored 0% for Lymphocyte, Monocyte/Mixed, White Blood Cell Count, Lymphocyte, Ganulocyte, Red Blood Cell Count, Hemoglobin, Hematocrit, and Platelet count for events B and C -2021 with the AAFP. 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 an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the Laboratory Director (LD) failed to provide appropriate direction to laboratory personnel to ensure that the PT surveys are performed satisfactorily and that the laboratory is in compliance with the CLIA regulations. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to ensure that all Testing Personnel (TP) who performed Hematology tests participated in the American Academy of Family Practioner's (AAFP) PT events in the calendar years 2019 and 2020. The finding includes: 1. A review of all PT events revealed that only one out of two TP performed PT all events in 2019 and 2020. 2. The TP #1 listed on CMS form 209 confirmed on 4/21/21 at 10:30 am that PT events were not rotated between TP. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(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 surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to attain at least 80% or more for Hematology tests performed on the Medonic M series analyzer with the American Academy of Family Physician (AAFP) in the 2018-B events. The findings include: 1. The laboratory scored 60% in 2018 - B on samples HD-6 and HD-7 for the following parameters; a. White Blood Cell Counts b. Lymphocyte % c. Monocyte mixed % d. Granulocyte % e. Red Blood Cells f. Hemoglobin g. Hematocrit h. Mean Corpuscular Volume (MCV) i. Platelet 2. There was no documented evidence the failures mentioned above were investigated. 3. The TP #5 listed on CMS form 209 confirmed on 1/31/19 at 10:40 am that the laboratory failed to attain an 80% or more for Hematology tests. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to evaluate results when they received an unacceptable score in Hematology tests performed on the Medonic M series analyzer with the American Academy of Family Physician (AAFP) in the 2017- Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- C event. The findings include: 1. The laboratory received "Fail" in 2017 - C on samples HD-13 for Mean Corpuscular Volume (MCV) and HD-15 for Lymphocyte % . 2. There was no documented evidence that the laboratory investigated the failures. 3. The TP #5 listed on CMS form 209 confirmed on 1/31/19 at 10:42 am that the laboratory did not perform and document an evaluation of unacceptable PT results. 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 the Procedure Manual, review of Quality Control (QC) data and interview with the Testing Personnel (TP), the laboratory failed to follow the QC lot to lot verification procedure from September 2017 to March 2018. The findings include: 1. The PM stated " Before putting a new lot of control materials in use verify the new control by parallel testing with the current lot." 2. The laboratory did not parallel test new QC lots as follows: a. Lot 21705 expired 9/28/17 - New Lot 21708 was verified 10/3/17 b. Lot 21708 expired 12/27/17 - New Lot 21711 was verified 1/2/18 c. Lot 21711 expired 3/27/18 - New Lot 21802 was verified 3/28/18 3. The TP # 5 listed on the CMS form 209 confirmed on 1/31/19 at 11:50 am that the QC procedure above was not followed. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)