Cancer And Hematology Centers Of Western

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the technical supervisor, the laboratory failed to label its hematology control materials with the expirations date reflecting its change in stability once opened for three (lot numbers 53361101, 53361102, and 53361103) of three control materials observed. Findings include: 1. The surveyor observed three XN CHECK lot numbers 53361101, 53361102, and 53361103 hematology controls on 1/6/26 at 9:13 am in the refrigerator with "O:12/22 /25" written on them, indicating the open date. 2. A review of the "XN Check" instructions for use included a section titled "Storage and shelf life after first opening" stating, "Open vials and vials which have been sampled by cap piercing will retain stability for 7 days if stored at 2-8 degrees C after being re-capped." showing a change in stability once a set has been put into use. 3. A review of the laboratory's "Quality Control Policy" included a section titled "Stability of Controls" stating, "The for Sysmex XN Control, Cancer& Hematology has proven by months of data collection that the controls are stable for 14 days once the control material is put into use. The 14 day stability will be standard operating procedure instead of the package insert stability recommendations." 4. An interview on 1/6/26 at 9:13 am with the technical supervisor confirmed the controls did not include the expiration date of the controls reflecting the change in stability for open vials. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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): 493.1252(d) (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 observation, record review, and interview with the technical supervisor, the laboratory failed to ensure hematology control materials were not used beyond their expiration dates for three (lot numbers 53361101, 53361102, and 53361103) of three control materials observed. Findings include: 1. The surveyor observed three XN CHECK lot numbers 53361101, 53361102, and 53361103 hematology controls on 1/6 /26 at 9:13 am in the refrigerator with "O:12/22/25" written on them, indicating the open date. 2. A review of the "XN Check" instructions for use included a section titled "Storage and shelf life after first opening" stating, "Open vials and vials which have been sampled by cap piercing will retain stability for 7 days if stored at 2-8 degrees C after being re-capped." showing a change in stability once a set has been put into use. 3. A review of the laboratory's "Quality Control Policy" included a section titled "Stability of Controls" stating, "The for Sysmex XN Control, Cancer& Hematology has proven by months of data collection that the controls are stable for 14 days once the control material is put into use. The 14 day stability will be standard operating procedure instead of the package insert stability recommendations." 4. A review of the control results performed 1/6/26 revealed control testing was performed at 7:18 am. 5. An interview on 1/6/26 at 12:03 pm with the technical supervisor confirmed the controls listed above had exceeded the expiration date. A total of 63 patients were performed prior to the reanalysis of newly opened controls at 1:45 pm. -- 2 of 2 --

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 review of the CMS database and review of the American College of Physicians Medical Laboratory Evaluation final proficiency testing reports, it was determined that the laboratory failed to successfully participate in a CMS approved proficiency testing program for the chemistry analyte chloride for 2 (events 2 and 3 of 2019) of 3 testing events in 2019. Findings include: Review of the CMS database and the American College of Physicians Medical Laboratory Evaluation proficiency testing reports showed unsatisfactory performance for events 2 and 3 of 2019 for the chemistry analyte: Chloride. Refer to D2087 and D2096. 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 -- 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 of the CMS database and the American College of Physicians Medical Laboratory Evaluation proficiency testing reports, the laboratory failed to attain a score of at least 80% of acceptable responses for the chloride analyte, which is unsatisfactory performance for the testing events for 2 (events 2 and 3 of 2019) of 3 testing events in 2019. Findings include: PT Event Chloride Score 2nd event 2019 20% 3rd event 2019 0% 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 review of the CMS database and the American College of Physicians Medical Laboratory Evaluation proficiency testing reports, the laboratory failed to attain a score of at least 80% of acceptable responses for the chloride analyte, which is unsatisfactory performance for 2 (events 2 and 3 of 2019) of 3 the testing events in 2019. Findings include: Unsatisfactory performance for 2 of 3 consecutive proficiency testing events constituting unsuccessful performance for chloride: PT Event Chloride Score 2nd event 2019 20% 3rd event 2019 0% -- 2 of 2 --