Valley Regional Hospital

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory (lab) failed to demonstrate that it can obtain performance specifications for accuracy, precision and reportable range before performing routine chemistry, toxicology and hematology testing on patient samples in May 2023. Findings include: 1. Review on 2/2/2024 of the lab's test list revealed a new instrument (Nova Prime Plus) used for hydrogen concentration (pH), partial pressure of carbon dioxide (pCO2), partial pressure of oxygen (pO2), total hemoglobin, oxygenated hemoglobin (HbO2), carboxyhemoglobin (HbCO2), and methemoglobin (MetHb). The test list showed a combined annual test volume of 1,205. 2. Review on 2/2/2024 of verification procedures for a new blood gas analyzer revealed the manufacturer's representative performed the verification procedures beginning in March 2023. The Lab Director (LD) signed in approval of the manufacturer's verification of performance specifications on May 5/18/2023, after which the lab began testing patient samples. 3. Interview on 2/2/2024 at 9:00 a.m. with the Technical Consultant (TC) confirmed the above findings and revealed the lab performed a correlation study with the previous instrument but did not perform testing to verify performance specifications for accuracy, precision and reportable range. 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 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 record review and staff interview, the laboratory failed to successfully participate in chemistry proficiency testing (PT) in 2018 and 2019. Findings include: 1) The laboratory obtained unsatisfactory performance scores for carbondioxide partial pressure (pCO2) analyte PT events in 2018 and 2019. Refer to tag D2087. 2) The laboratory obtained unsatisfactory performance scores for pCO2 in two consecutive events in 2018 and 2019 resulting in unsuccessful participation. Refer to tag D2096. D2087 ROUTINE CHEMISTRY 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): 493.841(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 record review and staff interview, the laboratory failed to attain a score of at least 80 percent of acceptable responses for the same analyte in two consecutive chemistry proficiency testing (PT) events in 2018 and 2019 resulting in unsatisfactory performance. Findings include: 1) Review on 7/8/2019 of Accutest PT results revealed the laboratory attained a score of 60% for carbondioxide partial pressure (pCO2) in the 3rd event of 2018 and attained a score of 60% for pCO2 in the 1st event of 2019. 2) Review on 7/8/2019 of the CLIA CASPER report 0155D revealed the laboratory attained a score of 60% in the 3rd event of 2018 and attained a score of 60% in the 1st event of 2019 for pCO2. 3) Phone interview on 7/8/2019 at 9:30 a.m. with the Technical Consultant confirmed the laboratory's pCO2 performance scores of 60% for both the 3rd event in 2018 and 1st event in 2019. 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 record review and staff interview, the laboratory failed satisfactory performance for the same chemistry anaylte in two consecutive proficiency testing (PT) events in 2018 and 2019 resulting in unsuccussful performance. Findings include: 1) Review on 7/8/2019 of Accutest PT results revealed the laboratory attained a score of 60% for carbondioxide partial pressure (pCO2) in the 3rd event of 2018 and attained a score of 60% for pCO2 in the 1st event of 2019. 2) Review on 7/8/2019 of the CLIA CASPER report 0155D revealed the laboratory attained a score of 60% in the 3rd event of 2018 and attained a score of 60% in the 1st event of 2019 for pCO2. 3) Phone interview on 7/8/2019 at 9:30 a.m. with the Technical Consultant confirmed the laboratory's pCO2 performance scores of 60% for both the 3rd event in 2018 and 1st event in 2019. -- 2 of 2 --