Cardinal Hill Rehabilitation Hospital

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 the desk review of chemistry proficiency testing results from the American Proficiency Institute (API), on 09/14/2021,the laboratory failed to sucessfully participate in two (2) chemistry testing events for Digoxin. See D2131. 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 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 desk review of Chemistry proficiency testing results from the American Proficiency Institute testing agency on 09/14/2021, the laboratory failed to successfully achieve satisfactory performance for the Digoxin analyte for two (2) testing events. Findings include: 1. The laboratory failed to achieve a satisfactory performance for the Digoxin (Dig) analyte in the first (1st) testing event of 2021 with a score of sixty percent (60%). 2. The laboratory failed to achieve a satisfactory performance for the Digoxin (Dig) analyte in the second (2nd) testing event of 2021 with a score of Zero percent (0%). -- 2 of 2 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on staff interview and record review on 03/12/2020, the laboratory failed to perform quality assessment for the specialties of hematology, chemistry and microbiology from 04/11/18 through 03/11/2020. Quality Assessment was not performed using pre-analytical, analytical and post analytical metrics. Findings include: 1. Policy review on 03/12/2020 at 10:15 AM revealed the policy only identified one (1) of three (3) metrics required for quality assessment activities from 04 /11/18 through 03/11/2020. 2. Record review revealed there was one (1) post analytical metric monitored from 04/11/18 through 03/11/2020. Further review revealed there was no documented evidence that pre-analytical or analytical quality measures were monitored and documented. 3. An interview with the technical supervisor on 03/12/2020 at 10:15 AM revealed there was not a system in place from 04/11/18 through 03/11/2020 to monitor pre-analytical, analytical, and post-analytical metrics. 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 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 -- 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 record review and staff interview on 03/12/2020, the laboratory failed to perform two (2) sensitivity controls each day of patient testing from 04/11/18 through 03/11/2020. Findings include: 1. Review of quality control records on 03/12/2020 at 2: 20PM revealed sensitivity controls were tested one (1) day per week of patient testing on the Vitek analyzer. 2. Interview with the technical supervisor at 2:20 PM on 03/12 /2020 revealed the laboratory failed to have a system in place to ensure control organisms were tested each day of patient testing. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on staff interview and record review on 04/10/2018, the laboratory failed to monitor and document the humidity of the laboratory where the testing was performed. Humidity was not recorded from April 20, 2016 through April 9, 2018. Findings include: Manufacturer's Instructions for the DXC-600 analyzer states that the analyzer recommend the Range of Humidity for the anayzer during operation to be between twenty percent (20%) and eighty five percent ( 85%). Manufacturer's Instructions for the XP-300 analyzer states that the analyzer recommend the Range of Humidity for the anayzer during operation to be between thirty percent (30%) and eighty five percent ( 85%). Review of Maintenance log revealed no documented evidence the humidity had been monitored April 20, 2016 through April 9, 2018. Testing personnel acknowledged in an interview at 1:10 pm on 04/10/2018, the laboratory failed to have a system in place to ensure the humidity was monitored and documented daily. 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 --