American Health Associates

Summary Statement of Deficiencies D0000 The purpose of this unannounced survey was for complaint MI00142373. The Department of Licensing and Regulatory Affairs has evaluated this facility and determined that it is not compliance with CLIA regulations (42 CFR Part 93, effective April 24, 2003). D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: . Based on record review and interview with the General Supervisor, the laboratory did not have a complaint system to document complaints reported to the laboratory for 2 (February 2022 to February 2024) of 2 years reviewed. Findings include: 1. The surveyor requested the laboratory's policy for complaint investigations on 2/21/24 at 12:00 pm and it was not made available during the survey. 2. An interview on 2/21/24 at 1:19 pm with the General Supervisor confirmed the laboratory had not established a complaint investigation policy to include documenting all complaints and problems reported to the laboratory. 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 D0000 The purpose of this unannounced survey was for complaint #MI00135038. The Department of Licensing and Regulatory Affairs has evaluated this facility and determined that it is in compliance with CLIA regulations (42 CFR Part 93, effective April 24, 2003). 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 D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . Based on record review and interview with the General Supervisor, the laboratory failed to establish policies to assess Clinical Consultant competency for 1 (Clinical Consultant #1) of 1 Clinical Consultant listed on Form CMS-209. Findings include: 1. A review of the laboratory's personnel records on 12/13/22 revealed a lack of competency assessment for Clinical Consultant #1 with a hire date of June 2021. 2. A review of the laboratory's competency assessment policies on 12/13/22 revealed a lack of policy for the performance of competency assessments for Clinical Consultants. 3. An interview on 12/13/22 at 1:08 pm with the General Supervisor revealed no competency assessment had been performed for Clinical Consultant #1. 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 record review and interview with the General Supervisor, the laboratory failed to perform calibration verification for its unsaturated iron-binding capacity (UIBC) testing at least every six months for 1 (December 2021 to December 2022) of 1 year reviewed. Findings include: 1. A review of the laboratory's calibration verification records revealed the UIBC analyte was absent from the following calibration verification testing events: a. December 2021 b. May 2022 c. November 2022 2. A review of the laboratory's "Beckman Coulter AU Series Unsaturated Iron Binding Capacity (UIBC)" procedure on 12/13/22 revealed the test system uses less than thee calibrators to perform its routine calibrations showing calibration verification is required. 3. An interview on 12/13/22 at 2:44 pm with the General Supervisor confirmed the laboratory failed to perform UIBC calibration verification at least every six months. **This is a repeated deficiency from the 6/22/21, 6/19/19, and 10/19/16 recertification surveys** -- 2 of 2 --

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 record review and interview with the General Supervisor, the laboratory failed to perform calibration verification activities at least every 6 months in 2020. Findings include: 1. A review of the laboratory's "Linearity Verification" procedure revealed a section stating, "As mandated by CLIA, laboratories must validate the Analytical Measurement Range (AMR) or method linearity initially, every six 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 -- months, and/or when calibration verification fails to meet the laboratories acceptable limits." 2. A review of the laboratory's calibration verification data revealed the following analytes did not have calibration verification performed at least every 6 months in 2020: a. Alkaline Phosphatase (ALP) had calibration verification performed on 9/4/20 and 5/11/21. b. Alanine Aminotransferase (ALT) had calibration verification performed on 9/4/20 and 5/11/21. c. Amylase had calibration verification performed on 9/4/20 and 5/11/21. d. Aspartate Aminotransferase (AST) had calibration verifcation performed on 9/4/20 and 5/11/21. e. Creatine Kinase had calibration verification performed on 9/4/20 and 5/11/21. f. Gamma-Glutamyl Transferase (GGT) had calibration verification performed on 9/4/20 and 5/11/21. g. Lactate Dehydrogenase (LD) had calibration verification performed on 9/4/20 and 5 /11/21. h. Lipase had calibration verification performed on 9/4/20 and 5/11/21. i. Total Bilirubin had calibration verification performed on 5/8/20 and 5/8/21. j. Direct Bilirubin had calibration verification performed on 5/8/20 and 5/8/21. k. High-Density Lipoproteins (HDL) had calibration verification performed on 6/17/20 and 5/8/21. l. Ferritin had calibration verification performed on 6/17/20. m. Albumin had calibration verification performed on 6/30/20 and 5/15/21. n. Blood Urea Nitrogen (BUN) had calibration verification performed on 6/30/20 and 5/15/21. o. Calcium had calibration verification performed on 6/30/20 and 5/15/21. p. Total Cholesterol had calibration verification performed on 6/30/20 and 5/15/21. q. Chloride had calibration verification performed on 6/30/20 and 5/15/21. r. Creatinine had calibration verification performed on 6/30/20 and 5/15/21. s. Glucose had calibration verification performed on 6/30/20 and 5/15/21. t. Potassium had calibration verification performed on 6/30 /20 and 5/15/21. u. Lithium had calibration verification performed on 6/30/20 and 5/15 /21. v. Magnesium had calibration verification performed on 6/30/20 and 5/15/21. w. Sodium had calibration verification performed on 6/30/20 and 5/15/21. x. Phosphorus had calibration verification performed on 6/30/20 and 5/15/21. y. Total Protein had calibration verification performed on 6/30/20 and 5/15/21. z. Triglycerides had calibration verification performed on 6/30/20 and 5/15/21. aa. Carbon Dioxide had calibration verification performed on 7/1/20. bb. Iron had calibration verification performed on 7/1/20. cc. Ammonia had calibration verification performed on 7/1/20. dd. Uric Acid had calibration verification performed on 7/1/20. 3. An interview on 6 /22/21 at 3:10 pm with the General Supervisor confirmed the laboratory did not perform calibration verification activities at least every 6 months for the above analytes. *** This is a repeated deficiency from the previous two surveys (6/19/19 and 10/19/16)*** D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: . Based on record review and interview with the General Supervisor, the laboratory failed to evaluate the correlation between different instruments performing the same testing at least twice annually for 1 of 2 events required in 2020. Findings include: 1. A review of the laboratory's "Instrument Correlations" procedure revealed a section stating, "The laboratory monitors and evaluates all methods for the same test -- 2 of 3 -- performed on different instruments. This evaluation is done at least twice a year, using five samples of each analyte monitored. The laboratory will monitor this policy using Proficiency Testing (PT) Acceptability Criteria and recording on an Instrument Correlation Log." 2. A review of the laboratory's instrument correlation data revealed the following instruments did not have instrument correlations twice annually in 2020: a. Beckman AU5800 Unit 1 System ID 42793798 chemistry analyzer had instrument correlations performed in 6/2020 b. Beckman AU5800 Unit 2 System ID 45196208 chemistry analyzer had instrument correlations performed in 6/2020 c. CA 1500 A SYS 1 SN 8816 coagulation analyzer had instrument correlations performed in 6/2020 d. CA 1500 A SYS 1 SN 8818 coagulation analyzer had instrument correlations performed in 6/2020 e. DxH A System ID 3820959 hematology analyzer had instrument correlations performed in 6/2020 f. DxH B System ID 3792459 hematology analyzer had instrument correlations performed in 6/2020 g. DxH C System ID 59545753 hematology analyzer had instrument correlations performed in 6 /2020 3. An interview on 6/22/21 at 3:10 pm with the General Supervisor confirmed the laboratory did not perform instrument correlations as least twice annually for the instruments listed above. in 2020 -- 3 of 3 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . Based on procedure review, observation, and interview with the Technical Supervisor (TS), the laboratory failed to label the Sigma-Aldrich Modified Wright Stain with the preparation dates, expiration dates, storage requirements, and lot numbers on the secondary containers for the current lot in use. Findings include: 1. A review of the "Manual Preparation and Staining of Blood Smears in Hematology - Wright Stain" procedure revealed the section stating, "Label the stain container in use (secondary container) with the following: Wright Stain, Store at RT, Lot # and expiration date, appropriate SDS hazard pictogram." 2. On 6/19/19 at 11:05 am during a tour of the laboratory, the surveyor observed the Sigma-Aldrich Modified Wright Stain without the preparation, expiration dates, storage requirements, and lot numbers on the secondary containers for the current lot in use. 3. An interview on 6/19/19 at 11: 15 am with the TS confirmed the secondary containers had not been labeled to include preparation dates, expiration dates, storage requirements, and lot numbers. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at 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 -- least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . A. Based on observation, record review, and interview with the Technical Supervisor (TS), the laboratory failed to perform and document laboratory thermometer calibration for 2 (2017 and 2018) of 2 years. Findings include: 1. On 6/19/19 at 8:59 am the surveyor observed the following thermometer calibration expiration dates: a. Refrigerator #1 had a thermometer with a calibration expiration date of October 2016. b. The freezer had a thermometer with a calibration expiration date of October 2018. c. Refrigerator #3 had a thermometer with a calibration expiration date of October 2018. d. The storage room had a thermometer with a calibration expiration date of October 2017. 2. A review of the "Thermometer Calibration Using NIST Calibrated Thermometer" procedure revealed thermometers were to be "tested against the NIST certified thermometer before being put into use and annually thereafter." 3. A review of the "Thermometer Calibration Documentation Forms" revealed a lack of documentation of thermometer calibrations in 2017, 2018, and 2019. 4. An interview on 6/19/19 at 8:59 am with the TS confirmed the laboratory failed to perform and document thermometer calibrations for 2017 and 2018. B. Based on document review and interview with the Technical Supervisor (TS), the laboratory failed to document Beckman Coulter UniCel DxH hematology analyzer background counts for 4 (patients 2, 4, 6, and 7) out of 5 patient charts reviewed. Findings include: 1. A record review of the Beckman Coulter UniCel DxH hematology analyzer daily checks revealed a lack of documentation of background counts for the following dates reviewed: a. 12/7 /18 b. 4/10/18 c. 11/7/17 d. 7/13/17 2. A review of patient charts revealed Complete Blood Counts (CBC) were reported for the following patients for the following days without documentation of background counts performed: a. Patient #2 performed on 12/7/18 b. Patient #4 performed on 4/10/18 c. Patient # 6 performed on 11/7/17 d. Patient #7 performed on 7/13/17 3. An interview on 6/19/19 at 4:06 pm with the TS confirmed the Beckman Coulter UniCel DxH hematology analyzer background counts were not documented for the 4 patient charts reviewed. 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 -- 2 of 3 -- calibration verification. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Supervisor (TS), the laboratory failed to perform and evaluate the chemistry and endocrinology calibration verification at least once every 6 months for 1 (January 2019 event) of 4 events reviewed. Findings include: 1. When requested on 6/19/19, the laboratory was not able to provide documentation showing the calibration verification was completed at least every 6 months in 2019 for the following chemistry and endocrinology testing: a. Endocrinology- T Uptake and T4 b. Chemistry - sodium, potassium, chloride, calcium, blood urea nitrogen, creatinine, total protein, lactate dehydrogenase, magnesium, phosphorous, uric acid, cholesterol, triglycerides, high density lipoprotein, total iron binding capacity, gamma-glutamyl transferase, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct bilirubin, alkaline phosphatase, C-reactive protein, prealbumin, albumin, creatinine kinase, amylase, lipase, lithium, and ferritin. 2. An interview on 6/19/19 at 11:30 am with the TS confirmed calibration verification had not been performed at least every 6 months in 2019. -- 3 of 3 --