Jacobson Memorial Hospital Care Center

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on record review, staff interview, and policy/procedure review, the laboratory failed to perform a positive and negative control each day of patient testing for Influenza A and B (Flu A & B), respiratory syncytial virus (RSV), and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) molecular tests using the Cepheid GeneXpert Dx System for 8 of 8 patient testing days (11/02, 11/04, 11/05, 11/21, 11 /22, 11/23, 11/25, and 11/30) in November 2024. The laboratory performed 44 patient tests on days with no quality control (QC) performance in November 2024. Findings include: 1. Reviewed on 12/30/24, the patient testing records for the Cepheid Quad Test (Flu A & B, RSV, and SARS-CoV-2) using the Cepheid GeneXpert Dx System indicated performance of the following patient tests in November 2024: 11/02 - one patient, 11/04 - one patient, 11/05 - one patient, 11/21 - two patients, 11/22 - one patient, 11/23 - two patients, 11/25 - two patients, and 11/30 - one patient. 2. Reviewed on 12/30/24, the November 2024 QC records for Flu A & B, RSV, and SARS-CoV-2 failed to include evidence of the performance of positive and negative controls on the following patient testing days: 11/02, 11/04, 11/05, 11/21, 11/22, 11 /23, 11/25, and 11/30. 3. During interview at 2:15 p.m. on 12/30/24, a technical consultant (#1) confirmed the laboratory failed to perform QC each day of patient testing for Flu A & B, RSV, and SARS-CoV-2 using the Cepheid GeneXpert Dx System. 4. Reviewed on 12/30/24, the policy/procedure "Laboratory: Xpert Xpress CoV-2/Flu/RSV plus," dated 11/29/21, stated, ". . . Quality Control . . . External controls should be used in accordance with local, state, and federal accrediting organizations as applicable. Cepheid recommends that all laboratories perform 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 -- external QC with each new lot and shipment of reagents, at a minimum . . ." The policy/procedure failed to require the performance of a positive and negative external control each day of patient testing. -- 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 American Proficiency Institute proficiency testing record review and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the analyte alanine transaminase for two consecutive events in 2018 (Events 2 and 3), resulting in unsuccessful performance. (Refer to D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing record review and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the analyte alanine transaminase (ALT) in two consecutive events in 2018 (Events 2 and 3), resulting in unsuccessful performance. Findings include: 1. Review of 2018 American Proficiency Institute (API) proficiency testing reports on 10/08/18 for the analyte ALT revealed the following results: Event 2-2018 - 60% Sample Lab Results Acceptable Range #06 135 124 - 187 #07 64 68 - 103 #08 208 178 - 268 #09 40 49 - 75 #10 185 163 - 246 Event 3-2018 - 60% Sample Lab Results Acceptable Range #11 30 41 - 63 #12 120 112 - 169 #13 180 155 - 233 #14 75 77 - 116 #15 140 130 - 196 The specialty of chemistry requires a score of 80% or greater for satisfactory performance. 2. During a telephone interview at approximately 10:10 a.m. on 10/08/18, the laboratory director (#1) confirmed the laboratory had scored 60% in Events 2 and 3 in 2018 for ALT due to not reporting the correct reagent code to the proficiency company. -- 2 of 2 --