Lower Umpqua Hospital District Laboratory

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 Virology. Refer to D2064. D2064 VIROLOGY CFR(s): 493.831(e) Failure to achieve an overall testing event score of satisfactory performance for two 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 -- 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 failed to achieve an overall testing event score of satisfactory in two consecutive events in Virology. Findings include: 1. 1st event 2022 Virology = 73% 2. 2nd event 2022 Virology = 60% -- 2 of 2 --

Summary Statement of Deficiencies D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on the complainant's email statement, the blood bank record review and discussion with staff, the laboratory staff failed to follow the written delegation of duties specified by the laboratory director, signed and dated on June 29, 2020. Findings include: 1. The email sent by Complainant (previous laboratory manager) dated October 15, 2020, stated that a technologist started training a phlebotomist (A) on moderate and complex testing, including blood bank high complexity tests after the previous laboratory manager was placed on administrative leave August 28, 2020. . 2. A phone call Interview with Laboratory Director (LD) on October 16, 2020 at 9 am confirmed that she had not authorized the phlebotomist(A) to be trained in blood bank or work in blood bank. The LD carefully reviewed the blood bank log book for testing activity for the month of September 2020 and found evidence of training documentation, which she had totally missed in her first review of blood bank activities. 3. Evidence of the phlebotomist(A)'s initials were documented on 09/19 /2020 at 1415 with co-sign initials of the medical technologist on blood bank log sheet with a comment "training for MLT Program". 4. The medical technologist was assigned to perform blood bank tests as a high complexity testing personnel however, 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 -- there were no responsibilities or duties specified in writing by current laboratory director for providing training to the phlebotomist(A) laboratory staff. 5. The complaint is substantiated. D6174 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(a) Each individual performs only those high complexity tests that are authorized by the laboratory director and require a degree of skill commensurate with the individual's education, training or experience, and technical abilities. This STANDARD is not met as evidenced by: Based on an email from complainant, review of records and interview conducted on an unannounced onsite CLIA investigation, the laboratory staff failed to ensure only Laboratory Director approved individuals with the required degree of skill commensurate with required education training or experience and technical abilities may perform blood bank high complexity tests. findings include: 1. The email sent by Complainant (previous laboratory manager) dated October 15, 2020, stated that a technologist started training a phlebotomist (A) on moderate and complex testing, including blood bank high complexity tests after the previous laboratory manager was placed on administrative leave August 28, 2020. 2. Record review confirmed Blood Bank log sheet entry dated September 19, 2020 at 1415, has documentation of patient ID 0919:BB00001R , specimen ID YAKT 1972, with test results for a type and screen. The blood bank tests, ABO Grouping , Rh Typing and Antibody Detection, were performed and resulted with initials of blood bank technologists, cosigned by phlebotomist(A) on the additional comment documented as "Training for MLT program". 3. On an unannounced onsite CLIA investigation October 1, 2020, record review of the phlebotomist(A) testing personnel's academia, training and competency records and review of the written delegations of duties authorized and signed June 29, 2020 by the current laboratory director, revealed this individual did not qualify as high complexity testing personnel and was not authorized to be trained or to perform blood bank tests. 4. Also, on the unannounced onsite CLIA investigation October 1, 2020 phlebotomist(A) was interviewed at 10:30 am by the CLIA surveyor regarding her assigned laboratory duties. This individual stated that she was trained to perform moderate complexity test by another laboratory manager, but is now only performing waived tests and assigned to phlebotomy . When asked specifically if she worked in blood bank, or was trained in blood bank, phlebotomist(A) clearly stated she is not allowed in blood bank and denied performing blood bank tests. Interviewed concluded at 11:00 am. 5. The complaint is substantiated. -- 2 of 2 --

Summary Statement of Deficiencies D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) from the American Association of Bioanalyst (AAB) the laboratory had unsatisfactory performance in Routine Chemistry. Findings include: 1. 3rd event of 2019 revealed 0% for the following analytes. pH, PCO2, and PO2. 2. No documentation of

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manuals and discussion with the staff the laboratory director did not sign and date the procedure manuals used in the laboratory. Findings include: 1. The surveyor reviewed all of the laboratory's procedure manuals and noticed that the new laboratory director did not sign and date any of the procedure manuals. 3. The laboratory did change to the new laboratory director effective 09/21/2017. 2. The laboratory manager concurred with these findings on 02/19/2019 at 17:00 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 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 -- 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 calibration records and discussion with staff the laboratory failed to perform calibration verification every six months for the D-dimer and Brain natriuretic peptide (BNP) test analytes using the Biosite Triage Meter. Findings include: 1. The surveyor requested and the laboratory failed to provide documentations of calibration verifications for BNP and D-dimer test analytes for the year 2017 and 2018. 2. The last documented calibration verifications of the BNP and D-dimer were 10/01/2016. 3. The laboratory manager concurred with these findings on 02/19/2019 at 17:00. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control procedures and quality control logs for serum Human Chronic Gonadotropin (HCG) test system and discussions with the laboratory staff the laboratory was not performing 2 levels of external controls (positive and negative) each day of patient testing. Findings include: 1. The surveyor reviewed the quality control logs for the Fisher Sure View HCG combo kits which can be used for both urine and serum. 2. The laboratory occasionally performed serum HCG but did not perform a positive and a negative control each time a serum specimen was used. 3. The surveyor requested but the laboratory failed to provide a written Individualized Quality Control Plan (IQCP) for the serum HCG test system. The laboratory follows the manufacturer's package insert (PI) in performing external quality control which was per new lot number and shipment of the test kits. 4. The laboratory manager concurred with these findings on 02/19/2019 at 17:00 D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the laboratory's policy and procedures, testing personnel (TP) -- 2 of 3 -- qualification and competency records, and quality control and calibration records the Laboratory Director (LD) did not fulfill her responsibilities to provide overall management and direction of the laboratory. Refer to D6102, D5407, D5439 and D6102. 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 discussions with the staff the laboratory failed to provide the necessary documentation of education of the testing personnel . Findings include: 1. The surveyor requested and the laboratory failed to provide the diplomas or transcript of records of 2 out of 4 new testing personnel (TP) that were hired on 03/2018 and 10/2018 at the time of survey. 2. The laboratory manager concurred with these findings on 02/19/2019 at 17:00 -- 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) shows the laboratory had unsuccessful participation for the Analyte Cortisol 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 = 35% 2. 3rd event of 2018 - Endocrinology = 75% 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 Cortisol. Findings include: 1. 2nd event 2018 - Cortisol = 20% 2. 3rd event 2018 - Cortisol = 0% -- 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 in Immunohematology. Refer to D2154 and D2182. D2154 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(b) Failure to attain an overall testing event score of at least 100 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 the American Association of Bioanalyst (AAB) proficiency testing shows unsatisfactory performance in ABO group and D (Rho) typing. Findings include: 1. 2nd Event 2018 - ABO - 80% 2. 2nd Event 2018 - ABO/RH - 90% D2182 ANTIBODY IDENTIFICATION CFR(s): 493.865(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Review of the American Association of Bioanalyst show unsatisfactoy performance in Anitbody Identification. Finding include: 1. 2nd Event of 2018 - Antibody Identification - 60% -- 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 2nd and 3rd event of 2017 for Compatibility Testing in Immunohematology. Refer to D2173 and D2179. D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 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 2 -- performance. This STANDARD is not met as evidenced by: PT desk review of the AAB PT reveals that the laboratory failed two consecutive testing events for compatibility testing for 2017. Findings include: 1. AAB PT 2nd event of 2017 Compatibility Testing - 80%. 2. AAB PT 3rd event of 2017 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: PT desk review of the AAB PT reveals that the laboratory failed two consecutive testing events for compatibility testing for 2017. Findings include: 1. AAB PT 2nd event of 2017 Compatibility Testing - 80%. 2. AAB PT 3rd event of 2017 Compatibility Testing - 80%. -- 2 of 2 --