Horn Memorial Hospital

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of Ortho Vitros calibration records, lack of calibration verification records and confirmed by laboratory personnel identifier #3 (refer to the Laboratory Personnel Report) at approximately 10:20 am on 12/16/2020, the laboratory failed to perform calibration verification every six months for one out of one time period for the analytes, vitamin D and vitamin B12, from 04/15/2020- 12/16/2020. The findings include: 1. The laboratory began using an Ortho Vitros XT 7600 chemistry analyzer 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 -- on 04/15/2020. 2. At the time of the survey, personnel identifier #3 confirmed that the laboratory did not perform calibration verification for the analytes, vitamin D and vitamin B12, during the time period between 04/15/2020 and 12/16/2020. -- 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 records and reports, the laboratory fails to successfully participate in a proficiency testing program for the analyte, compatibility testing, for two consecutive testing events: 2018 testing events 1 and 2 (refer to D2181). D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive 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 -- 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 reports and records, the laboratory fails to achieve satisfactory performance for the analyte, compatibility testing, for two out of two testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 60% for 2018 testing event 1 and 80% for 2018 testing event 2. -- 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 and interview with laboratory personnel identifier #9 (refer to Laboratory Personnel Report) at approximately 9:30 am on 09/20/2018, the laboratory failed to enroll in an approved proficiency testing program for two out of two years (2017 and 2018) for the subspecialty, bacteriology - throat cultures. The findings include: 1. During the tour of the facility, laboratory personnel identifier #9 stated the laboratory performed throat cultures on all patients that had a negative rapid Group A Streptococcus test result. 2. At the time of the survey, the laboratory failed to enroll in an approved proficiency testing program for subspecialty, bacteriology - throat cultures. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. 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 -- This CONDITION is not met as evidenced by: Based on review of coagulation reagent studies, observations of the coagulation analyzer and confirmed by laboratory personnel identifier #9 (refer to the Laboratory Personnel Report) at approximately 1:30 pm on 09/20/2018, the laboratory failed to meet the hematology (coagulation) requirements for test system/equipment/reagent verification as specified in the standard D5411 (A and B). D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: A. Based on observations made during the survey, review of coagulation reagent studies and confirmed by laboratory personnel identifier #9 (refer to the Laboratory Personnel Report) at approximately 1:15 pm on 09/20/2018, the laboratory failed to program the correct normal patient mean for lot number N1072885, expiration date 10 /31/2019 of Prothrombin Time (PT) reagent into the ACL Elite coagulation analyzer. The findings include: 1. The laboratory must establish a normal patient mean with each new lot number of PT reagent. 2. For lot number N1072885, expiration date 10 /31/2019 of PT reagent the laboratory calculated a normal patient mean of 11.8 seconds. 3. At the time of the survey, the laboratory had programmed into the ACL Elite coagulation analyzer the normal patient mean as 10.8 seconds. 4. Laboratory personnel identifier #9, confirmed the laboratory programmed the wrong normal patient mean into the ACL Elite coagulation analyzer. B. Based on review of coagulation reagent studies and confirmed by laboratory personnel identifier #9 (refer to Laboratory Personnel Report) at approximately 1:30 pm on 09/20/2018, the laboratory failed to verify the manual calculation of the international normalized ratio (INR) using the correct normal patient mean value for one out of one lot number of Prothrombin time (PT) reagent (N1072885, expiration date 10/31/2019) in July 2018. The findings include: 1. For lot number N1072885, expiration date 10/31/2019 of PT reagent the laboratory calculated a normal patient mean of 11.8 seconds. 2. In July 2018, the laboratory verified a manual calculation of the INR incorrectly, using the normal patient mean of 11.1 seconds. 3. Laboratory personnel identifier #9, confirmed the laboratory used the wrong normal patient mean when verifying the manual calculation of the INR. C. Based on review of the throat culture procedure, QuickVue In-Line Strep A manufacturer's instructions, and confirmed by laboratory personnel identifier #9 (refer to the Laboratory Personnel Report) at approximately 2:00 pm on 09/20/2018, the laboratory failed to follow manufacturer's instructions and performed testing outside of the stated performance specifications while performing confirmatory Streptococcus Group A testing using the waived QuickVue In-Line Strep A test kit for one out of one patient (Patient identifier A) on 03/02/2018. The findings include: 1. Patient A had a throat culture performed on 03/02/2018. 2. The laboratory throat culture procedure stated, "At 48 hours, observe the blood agar plate by holding the plate up to the light and looking at the uncovered side of the agar. If beta hemolysis is present, retrieve a Rapid Strep A kit and using the swab from the kit collect colonies showing beta hemolysis. Place swab in test cartridge and proceed as indicated by the test kit procedure." 3. The QuickVue In-Line Strep A manufacturer's -- 2 of 3 -- instructions stated, "The QuickVue In-Line Strep A Test allows for the rapid detection of Group A Streptococcal antigen directly from patient throat swab specimens." The manufacturer's instructions do not allow for confirmatory testing to be performed directly from a blood agar plate. 4. At the time of the survey, the laboratory failed to follow manufacturer's instructions and performed testing outside of the stated performance specifications when performing confirmatory throat cultures. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of media records and confirmed by laboratory personnel identifier #9 (refer to Laboratory Personnel Report) at approximately 2:30 pm on 09/20/2018, the laboratory failed to check each lot of media for sterility and the ability to support growth for two lot numbers of media (lot numbers 384932 and 381082) received in September 2018. The findings include: 1. The laboratory retained the manufacturer's quality control (QC) certificates for lot number 384932, expiration date 10/16/2018 and lot number 381082 expiration date 10/09/2018 of blood agar 5% sheep blood. 2. Laboratory personnel identifier #9 indicated that the laboratory intended to retain the manufacturer's QC certificates and not perform additional QC. 3. At the time of the survey, the laboratory did not have an Individualized Quality Control Plan (IQCP) for media. -- 3 of 3 --