Spencer Hospital

Summary Statement of Deficiencies 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 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 lack of Individualized Quality Control Plan (IQCP) records, review of quality control (QC) records, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at 8:51 am on 08/27/2024, the laboratory failed to perform two levels of quality control each day of patient testing for the following test systems: Bio-Rad Tox-See urine drug screen, Remel Xpect Clostridium difficile, Adeza TLiQ fetal fibronectin, and Cardinal qualitative serum human gonadotropin chorionic (HCG). The findings include: 1. The laboratory performed QC with each new lot and shipment of tests and monthly for the Bio-Rad Tox-See urine drug screen test system. 2. The laboratory performed QC with each new lot and shipment of tests for the Remel Xpect Clostridium difficile, Adeza TLiQ fetal fibronectin, and Cardinal qualitative serum HCG test systems. 3. Laboratory personnel identifier #1 indicated that the laboratory intended to follow the manufacturer's instructions for performing QC. 4. At the time of the survey, the laboratory did not have an IQCP for the test systems listed above. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) 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 -- (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of immunohematology records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at 9:49 am on 08/27 /2024, the laboratory failed to perform comparison studies between the automated Ortho Vision Swift and manual Ortho MTS gel card systems for immunohematology testing twice annually for two out of two semiannual time periods from 06/01/2023- 06 /30/2024. The findings include: 1. The laboratory implemented and began using the Ortho Vision Swift automated analyzer to perform immunohematology testing in April 2023. 2. Personnel identifier #1 confirmed that the laboratory uses the manual Ortho MTS gel card system as a back-up test system. 3. At the time of the survey, personnel identifier #1 confirmed that the laboratory did not perform and document twice annual comparisons for the Ortho Vision Swift and manual Ortho MTS gel card test systems from 06/01/2023- 06/30/2024. D5783

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 proficiency testing (PT) records and reports, the laboratory failed to successfully participate in a PT program for the analyte, digoxin, for two consecutive testing events: 2023 event 3 and 2024 event 1 (refer to D2118). D2118 TOXICOLOGY CFR(s): 493.845(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 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) reports and records, the laboratory failed to achieve satisfactory performance for the analyte, digoxin, for two consecutive PT events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 60% for 2023 testing event 3 and 60% for 2024 testing event 1. -- 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 review of proficiency testing records, the Spencer Hospital Laboratory Test List & Annual volume form, quality control and calibration records, and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 3:00 pm on 09/19/2022, the laboratory failed to enroll in an approved proficiency testing program for the analyte, fibrinogen in 2022. The findings include: 1. The Spencer Hospital Laboratory Test List & Annual volume form lists fibrinogen testing as being performed by the laboratory. 2. The laboratory performed quality control for the analyte, fibrinogen for the month of May 2022. 3. The laboratory performed calibration of the analyte, fibrinogen on 1/21/22 and 7/27/2022. 4. At the time of the survey, the laboratory did not enroll in an approved proficiency testing program in 2022 for the analyte, fibrinogen. 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 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 -- (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 of proficiency testing (PT) records and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 3:00 pm on 09/19/2022, the laboratory failed to perform a self evaluation of ungraded PT scores for four out of five PT testing events from 1/1/2021 - 9/20/2022. The findings include: 1. For 2021 testing event 1, the laboratory received ungraded PT test scores for the following: *Beta lactamase, specimen ES-01; *Gentamicin synergy ES-01; *Cerebrospinal fluid minimum inhibitory concentration value, specimen SF-01; *Cerebrospinal fluid susceptibility interpretation, specimen SF-01; *Stool culture, specimen SC-01; *Urine culture minimum inhibitory concentration value, specimen UR-01; and *Urine culture susceptibility interpretation, specimen UR-01. 2. For 2021 event 2, the laboratory received ungraded PT test scores for the following: *Folate, specimen IA-07 and IA-08. 3. For 2022 testing event 1, the laboratory received ungraded PT test scores for the following: *Cerebrospinal fluid minimum inhibitory concentration value, specimen SF-01; *Gram stain, specimen GS-05; and *Urine culture minimum inhibitory concentration value, specimen UR-01. 4. For 2022 testing event 2, the laboratory received ungraded PT test scores for the following: *Urine culture minimum inhibitory concentration value, specimen UR-06; *Urine culture susceptibility interpretation, specimen UR-01; and *Compatibility testing, specimen ER-06. 5. At the time of the survey, the laboratory did not perform a self evaluation for the above ungraded PT test scores. D5507 BACTERIOLOGY CFR(s): 493.1261(b)(c) (b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved control organisms. (b)(1) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(2) The laboratory's zone sizes or minimum inhibitory concentration for control organisms must be within established limits before reporting patient results. (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on Individualized Quality Control Plan (IQCP), review of antimicrobial susceptibility testing (AST) quality control (QC) and patient test reports, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 12:00 pm on 09/20/2022, the laboratory failed to ensure minimum inhibitory concentrations fell within the established limits for one out four weeks of patient testing in May 2022. The findings include: 1. The Susceptibility IQCP stated that the laboratory would perform susceptibility testing QC weekly. 2. On 5/23/22, the laboratory performed QC using the organism Streptococcus pneumoniae on the Gram positive Streptococcus species (AST-ST02) card (lot number 541203523, expiration date 6/23/2023). The laboratory established range a of 0.25 - 1 for the antibiotic, benzylpenicillin for this specific lot number of AST-ST02 cards using the organism Streptococcus pneumoniae. 3. On 5/23/22, the laboratory received a result -- 2 of 3 -- of TRM (terminated result) for the antibiotic benzylpenicillin for this specific lot number of AST-ST02 cards using the organism Streptococcus pneumoniae. 4. The laboratory performed testing on 2 patients using the AST-ST02 susceptibility card the week of 5/23/2022. 5. At the time of the survey, the laboratory did not document

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of hematology quality control (QC) records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 5:00 pm on 11/11/2020, the laboratory failed to retain hematology complete blood count (CBC) QC records for three out of three lot numbers of QC and 28 out of 61 days from 04/01/2020-05/31/2020. The findings include: 1. The laboratory performed three levels of CBC QC for each 24-hour period of patient testing. 2. At the end of use for each lot number, the laboratory printed the QC files stored on the hematology instrument and kept them as documentation of QC results. 3. The laboratory's records indicated that QC parameters were entered into the Beckman Coulter DXH 600 hematology instrument on 04/16/2020 for the following new lot numbers: 123173100, expiration 2020-05-16 (low); 133183100, expiration 2020-05-16 (normal); and 143193100, expiration 2020-05-17 (high). 4. Review of printed QC records revealed that the laboratory did not have QC records from 04/20 /2020- 05/17/2020. 5. Laboratory personnel identifier #2 stated that the QC files for lot numbers 123173100, 133183100 and 143193100 had been deleted before they could be printed and that the hematology instrument did not store more than the current and previous set of QC files. 6. At the time of the survey, the laboratory did not have additional QC records from 04/20/2020- 05/17/2020. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 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 lack of Individualized Quality Control Plan (IQCP) records, review of 2018 quality control (QC) records, and confirmed by laboratory personnel identifier #2 (refer to Laboratory Personnel Report) at approximately 12:30 pm on 08/08/2018, the laboratory failed to perform a positive and negative control each day of patient testing for the Streptococcus pneumoniae antigen and Mycoplasma pneumoniae test kits. The findings include: 1. The laboratory performed a positive and negative external QC with each new lot and shipment of the Streptococcus pneumoniae antigen and Mycoplasma pneumoniae test kits. 4. Laboratory personnel identifier #2 indicated that the laboratory intended to follow manufacturer's instructions for performing QC. 5. At the time of the survey, the laboratory did not have an IQCP for either test kit. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --