Cancer And Hematology Centers, The

Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Supervisor, the laboratory failed to test its peripheral blood smear staining materials for predictable staining characteristics at least each day of patient testing for 2 (June 2021 to June 2023) of 2 years reviewed. Findings include: 1. A review of the laboratory's "Manual Differential Procedure" revealed a section titled "Quality Control" stating, "When a new lot of stain is put into use, a slide is reviewed to make sure the cells are stained appropriately." 2. A review of the laboratory's "Wright Stain Log Sheet" revealed the laboratory only documented stain quality when it put a new lot of staining materials into use. 3. An interview on 6/20/23 at 11:37 am with the Technical Supervisor confirmed the laboratory had not established a practice of documenting its peripheral blood smear staining materials for predictable staining characteristics each date of patient testing. D5813 TEST REPORT CFR(s): 493.1291(g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. 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 -- This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Supervisor, the laboratory failed to follow its policy to immediately report critical results for 1 (Patient 129758) of 12 patient test reports reviewed. Findings include: 1. A review of the laboratory's "Laboratory Test Documentation" policy revealed a section stating, "If any critical results are obtained as defined on the critical values chart, do the following: a. Repeat to confirm results b. Notify the physician or designee ASAP by sending a task in the EMR (electronic medical record). Include date, time and initials of the sender in the task." 2. A review of patient test reports and the critical values chart revealed Patient 129758 had a Complete Blood Count (CBC) performed on 7/25/22 with a critically high white blood cell count. 3. The surveyor requested documentation showing Patient 129758's white blood cell result was reported according to the laboratory's policy on 10:41 am and it was not made available. 4. An interview on 6/20/23 at 10:41 am with the Technical Supervisor revealed the laboratory had not reported the critical result according to its policy. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: . Based on a lack of documentation and interview with the Technical Consultant (TC), the laboratory failed to enroll in an approved proficiency testing program for serum human gonadotropin (hCG) testing for 2 (November 2019 to November 2021) of 2 years reviewed. Findings include: 1. A review of the laboratory's proficiency testing records revealed a lack of documentation of testing for serum hCG testing, a test listed on the test menu given to the surveyor. 2. An interview on 11/08/2021 at 10:15 am with the TC confirmed the laboratory had not enrolled in an approved proficiency testing program for the serum hCG testing. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number 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 -- and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant (TC), the laboratory failed to perform quality control each day of patient testing for the serum human chorionic gonadotropin (hCG) testing for 2 (November 2019 to November 2021) of 2 years reviewed. Findings include: 1. A "In-House Test Menu CHC Holland" was presented to the surveyor upon arrival that included serum hCG. 2. When queried on 11/08/2021 at 10:15 am, the surveyor requested a copy of the manufacturer's product instructions, a total count of tests performed over 2 years, and documentation of the external quality control results. 3. The manufacturer's instructions for the "ICON 25 hCG" revealed the serum hCG testing to be a moderately complex test. 4. A "Order Choice Utilization Report" was pulled from 11 /05/2019 to 11/05/2021 that indicated that 58 serum hCG tests had been performed. 5. A lack of documentation to show that every day of patient testing an external positive and negative control were performed and documented and that an individual quality control plan (IQCP) had not been developed or put into place for 2 (November 2019 to November 2021) of 2 years of testing. 6. An interview on 11/08/2021 at 10:15 am, the TC confirmed serum hCG testing was being performed and that external positive and negative controls were not performed and documented each day of patient testing. -- 2 of 2 --