Lake District Hospital

Summary Statement of Deficiencies D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with the Technical Supervisor (TS) the Laboratory Director (LD) failed ensure that all Testing Personnel (TP) have the appropriate education and experience and were trained and competent to perform the test prior to patient testing. Findings include. 1. One (1) out of three (3) TP listed on the CMS form 209 from the Respiratory Department performing arterial blood gas using the I Stat analyzer do not have diploma or transcript of records and no documentation of six month and annual competency assessment at the time of the survey. This TP was hired on 07/15/2021. 2. The Respiratory Department perform approximately 44 arterial blood gas per year. 3. The TS confirmed these findings during the interview on 05/11/2023 @ 15:30 PM. 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: Proficiency Testing (PT) desk review of the American Association of Bioanalysts (AAB) proficiency testing showed the laboratory had unsuccessful participation for two consecutive testing event 1st and 2nd event 2022 in the specialty Endocrinology and Immunohematology. Refer to D2099, D2107, D2173, D2179 and D2181. D2099 ENDOCRINOLOGY CFR(s): 493.843(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory 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 -- performance. This STANDARD is not met as evidenced by: Proficiency Testing (PT) desk review of the American Association of Bioanalyst (AAB) showed the laboratory failed to attain an overall testing event score of 80 percent for two consecutive events in the specialty Endocrinology. Findings include: 1. 1st event 2022 Endocrinology = 33% 2. 2nd event 2022 Endocrinology = 33% D2107 ENDOCRINOLOGY CFR(s): 493.843(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: Proficiency Testing (PT) desk review of the American Association of Bioanalysts (AAB) proficiency testing showed the laboratory has had unsuccessful performance for two consecutive events for the analytes Free Thyroxine and Thyroid Stimulating Hormone in the specialty Endocrinology. Findings include: 1. 1st event 2022 Free Thyroxine = 0% 2. 2nd event 2022 Free Thyroxine = 0% 3. 1st event 2022 Thyroid Stimulating Hormone = 0% 4. 2nd event 2022 Thyroid Stimulating Hormone = 0% D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Proficiency Testing (PT) desk review of the American Association of Bioanalysts (AAB) proficiency testing showed the laboratory had failed to attain an overall testing event score of 100% for two consecutive events for Compatibility Testing in the specialty Immonohematology. Findings include: 1.. 1st event 2022 Compatibility Testing = 80%. 2. 2nd event 2022 Compatibility Testing = 80%. D2179 COMPATIBILITY TESTING CFR(s): 493.863(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unsatisfactory testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Proficiency Testing (PT) desk review of the American Association of Bioanalysts (AAB) proficiency testing showed the laboratory had unsuccessful performance for -- 2 of 3 -- two consecutive events for Compatibility testing in the specialty Immunohematology. Findings include: 1.1st event 2022 Compatibility Testing = 80%. 2. 2nd event 2022 Compatibility Testing = 80%. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Proficiency Testing (PT) desk review of the American Association of Bioanalysts (AAB) proficiency testing showed the laboratory had unsuccessful performance for two consecutive events for Compatibility testing in the specialty Immunohematology. Findings include: 1.1st event 2022 Compatibility Testing = 80%. 2. 2nd event 2022 Compatibility Testing = 80%. -- 3 of 3 --

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: Proficiency Testing (PT) desk review of the American Association of Bioanalysts (AAB) proficiency testing (PT) showed the laboratory had unsuccessful participation for 2nd event 2021 and 3rd event 2021 for the Specialty Hematology. Refer to D2130 and D2131. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in 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 -- 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 records the laboratory had 2 consecutive events failures for the analytes Hemoglobin and Hematocrit . Findings include: 2nd event 2021 a) Hemoglobin = 0% b) Hematocrit = 0% 3rd event 2021 a) Hemoglobin = 0% b) Hematocrit = 0% D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for 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 records the laboratory failed to achieve an overall satisfactory score for 2 consecutive events in the Specialty Hematology: Findings include: 1. AAB 2nd event 2021 Hematology = 77% 2. AAB 3rd event 2021 Hematology = 75% -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on inspection of reagents available for patient use in the laboratory, the laboratory failed to ensure that all reagents being used for patient testing were not expired. Findings include: 1. Upon inspection of reagents available for use near the microscope used for reading microscopic urines, it was found that two vials of URINE CHEK urine adulterant strips had expired. One in October 2017 and one in February 2018. Additionally, an expired bottle of potassium hydroxide (KOH) was also found, with an expiration date of May 2019. 2. Upon inspection of the area used for cytology, it was found that the vials of PROTOCOL fixative had expired in January 2017. 3. The Technical Supervisor (TS) confirmed the expiration dates had been overlooked during interview 6/3/2019 at approximately 1430. 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 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 -- 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 the iSTAT blood gas records and dicussion with the Technical Supervisor (TS), the laboratory failed to ensure the iSTAT instrument was calibrated every six (6) months. Findings include: 1. No evidence of Blood Gas calibration of the iSTAT instrument could be produced during the survey on 6/4/2019. 2. The TS verified during interview 6/4/2019 at approximately 1230 pm and later by email that the instrument had not been calibrated to her knowledge for five (5) years. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Microbiology Quality Control (QC) records and interview with staff, the laboratory failed to ensure QC was documented for the reagents/tests which require it. Findings include: 1. No written documentation for daily QC on Catalase, Coagulase, Indole or Cefinase could be provided. 2. No written documentation for weekly QC on gram staining could be provided. 2. The Technical Supervisor (TS) and testing personnel (TP) confirmed during an interview 6/4/2019 at approximately 12:00 that written documentation of the aforementioned reagents and tests did not exist. -- 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: Proficiency Testing (PT) desk review of the American Association of Bioanalysts (AAB) proficiency testing (PT) shows the laboratory had unsuccessful participation for the Analyte Free Thyroxine in Endocrinology. Refer to D2099 and D2107. D2099 ENDOCRINOLOGY CFR(s): 493.843(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory 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 2 -- This STANDARD is not met as evidenced by: Review of Proficiency testing shows the laboratory failed to attain an overall of 80 percent in Endocrinology. Findings include: 1. 2nd event of 2018 - Endocrinology = 66% 2. 3rd event of 2018 - Endocrinology = 66% D2107 ENDOCRINOLOGY CFR(s): 493.843(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: Review of Proficiency testing shows the laboratory failed two consecutive testing events for the analyte Free Thyroxine. Findings include: 1. 2nd event 2018 - Free Thyroxine = 0% 2. 3rd event 2018 - Free Thyroxine = 0% -- 2 of 2 --