Palo Alto County 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 review of the laboratory's Cepheid Individual Quality Control Plan (IQCP) and quality control (QC) records and confirmed by interview with the general supervisor at 10:07 am on 10/30/2024, the laboratory failed to perform two levels of QC for one out of one lot number of multiplex vaginal panel (MVP) cartridges in May 2024. 1. On 5/11/2024 the laboratory performed testing on patient identifier A using reagent lot number 02305, expiration date 1/26/25 of MVP cartridges. 2. The laboratory's IQCP stated that the laboratory would perform a positive and negative control with each new lot number and/or shipment of Cepheid MVP cartridges. 3. At the time of the survey, the laboratory failed to have records documenting positive and negative QC for reagent lot number 02305, expiration date 1/26/25 of MVP cartridges. D5503 BACTERIOLOGY CFR(s): 493.1261(a)(2) (a) The laboratory must check the following for positive and negative reactivity using control organisms: (a)(2) Each week of use for gram stains. 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 lack of gram stain quality control (QC) records and confirmed by interview with the general supervisor at 1:12 pm on 10/30/24, the laboratory failed to document weekly positive and negative gram stain controls for one out on one week of patient testing reviewed in May 2024. The findings include: 1. Patient identifier B had a urine culture with gram stain performed on 5/17/2024. 2. The general supervisor stated that the laboratory did not document weekly positive and negative gram stain QC, and that the laboratory performed gram stain QC with each wound culture work up. The general supervisor confirmed that there would be weeks when there would be no wound culture work ups. 3. At the time of the survey, the laboratory did not have documentation pf positive and negative gram stains controls being performed the week of 5/17/2024. -- 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 proficiency testing records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 11:45 am on 10/24/2022, the laboratory failed to successfully participate in a proficiency testing program for the analyte, human chorionic gonadotropin (HCG), for two out of three consecutive testing events: 2022 testing events 1 and 3 (refer to D2107). D2107 ENDOCRINOLOGY CFR(s): 493.843(f) 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 -- 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 proficiency testing (PT) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 11: 45 am on 10/24/2022, the laboratory failed to achieve satisfactory performance for the analyte, human chorionic gonadotropin (HCG), for two out of three consecutive PT events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 60% for 2022 testing event 1 and zero for 2022 testing event 3. D5783

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 and confirmed by laboratory personnel identifier #3 (refer to the Laboratory Personnel Report) at approximately 10:00 am on 11/28/2018, the laboratory failed to enroll in an approved proficiency testing program for two out of two years from January 2017- November 2018 for the subspecialty, parasitology - Trichomonas vaginalis (molecular method). The findings include: 1. The laboratory performs Trichomonas vaginalis testing on the Cepheid GeneXpert instrument. 2. At the time of the survey, the laboratory failed to enroll in an approved proficiency testing program for subspecialty, parasitology (molecular method) in 2017 and 2018 . D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. 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 review of maintenance records and confirmed by laboratory personnel identifier #3 (refer to the Laboratory Personnel Report) at approximately 10:40 am on 11/28/2018, the laboratory failed to document all monthly maintenance activities on the Cepheid GeneXpert instrument for one out of one month (May 2018) in 2018. The findings include: 1. The GeneXpert Maintenance log stated the laboratory must perform the following monthly: *archive runs *delete runs *disinfect GX surfaces *disinfect cartridge bay interior *disinfect plunger rod *dust buster 2. The laboratory documented that it had performed the "dust buster" activity on 05/01/2018, but had not documented performance of the rest of the monthly maintenance activities. 3. At the time of the survey, laboratory personnel identifier #3 confirmed that the laboratory only documented performance of the "dust buster" monthly activity for the month of May 2018. 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 review of the laboratory's Individualized Quality Control Plan (IQCP) and confirmed by laboratory personnel identifier #3 (refer to the Laboratory Personnel Report) at approximately 11:10 am on 11/28/2018, the laboratory failed to include a written quality assessment plan as part of the IQCP for the following test systems: ActimProm Rupture of Membranes (ROM) and Cardinal Health Crypto Giardia Rapid Test. -- 2 of 2 --