Altru Diagnostics Inc

Summary Statement of Deficiencies D0000 As a result of complaint TX00562383, an unannounced survey of the facility was conducted on 06/03/2026. The laboratory was found out of compliance with the CLIA regulations (42 CFR Part 493, Requirements for Laboratories). The CONDITIONS NOT MET were: D5300 - 42 C.F.R. 493.1240 Condition: Preanalytic systems; D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director; D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory's test add-on records, computerized specimen problem logs, Client Relations department's communications and specimen problem resolution records, patient test records, quality assurance and staff interview, the laboratory failed to ensure overall quality of preanalytic systems was maintained. Findings included: 1. The laboratory failed to ensure oral test requests for "Add On" tests were followed up with written or electonic autherizations. Refer to D5303. 2. The laboratory failed to ensure patient information was transcribed accurately into the Laboratory Information System. Refer to D5309. 3. The laboratory failed to ensure sample storage temperature monitoring was documented. Refer to D5311 A & B. 4. The laboratory's quality assurance failed to identify and correct issues in Client Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Relations specimen problem resolution documentation, written request documentation for Add-on tests, test order transcription and specimen storage temperature monitoring. Refer to D5391A, B, C and D. D5303 TEST REQUEST CFR(s): 493.1241(b) (b) The laboratory may accept oral requests for laboratory tests if it solicits a written or electronic authorization within 30 days of the oral request and maintains the authorization or documentation of its efforts to obtain the authorization. This STANDARD is not met as evidenced by: Based on the review of the laboratory's records, CR to the laboratory's emails, and confirmed in an interview, the laboratory failed to follow up 9 of 9 oral test requests from 5/12/2026 to 6/1/2026 with written or electronically authorized requests regarding additional testing that may be requested at a later date by a physician. The findings were: 1. Review of the laboratory's records revealed there was not a current policy in place regarding oral test requests, and what steps are necessary to properly accept oral test requests for additional testing. 2. In an interview on 06/03/2026 at 120: 20 pm in the clinical supervisor's office, the clinical supervisor stated the add-on test procedures were as followed: A) The client called CR to request additional testing to a patient with 2 patient identifiers. B) CR called or emailed the laboratory to check if the additional testing could be added to the original tubes. C) The laboratory called or emailed CR to confirm or reject the additional testing request. D) CR called the client back to confirm additional testing or rejection. 3. Review of the additional testing request emails from 5/12/2026 to 6/1/2026 from CR revealed the laboratory failed to follow up 9 of 9 oral test requests with written or electronically authorized requests regarding additional testing that may be requested at a later date by a physician. Collection Date: 05/12/2026 Accession#: 260513BM0370 Requested Date: 05/15 /2026 Additional testing requested: Lipid Panel Collection Date: 05/15/2026 Accession#: 260516BM0177 Requested Date: 05/18/2026 Additional testing requested: Urine culture and sensitivity Collection Date: 05/19/2026 Accession#: 260521BM0248 Requested Date: 05/20/2026 Additional testing requested: Alpha-Gal IgE Panel Collection Date: 05/26/2026 Accession#: 260527BM0038 Requested Date: 05/29/2026 Additional testing requested: Vitamin D Collection Date: 05/26/2026 Accession#: 260527BM0293 Requested Date: 05/28/2026 Additional testing requested: Vitamin D, CRP (C-Reactive Protein) Collection Date: 05/27/2026 Accession#: 260529BM0124 Requested Date: 06/01/2026 Additional testing requested: HgbA1C Collection Date: 05/28/2026 Accession#: 260528BM0627 Requested Date: 06/03/2026 Additional testing requested: FSH (Follicle-Stimulating HC-Rormone), LH (Luteinizing Hormone), Progesterone, Prolactin, Testosterone free /Total Collection Date: 06/01/2026 Accession#: 260602BM0370043 Requested Date: 06/02/2026 Additional testing requested: ANA by IFA Reflex to titer and pattern Collection Date: 06/01/2026 Accession#: 260602BM0310 Requested Date: 06/01 /2026 Additional testing requested: CK (Creatine Kinease), LDH (Lactate Dehydrogenase) 4. An interview on 06/03/2065 at 13:59 pm in the middle desk area, the clinical supervisor confirmed the above findings. Key: CR=Client Relation D5309 TEST REQUEST CFR(s): 493.1241(e) (e) If the laboratory transcribes or enters test requisition or authorization information -- 2 of 6 -- into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: Based on review of laboratory's computerized specimen problem logs, Client Relations department's specimen problem resolution records, patient test records and staff interview, the laboratory failed to ensure patient information was transcribed accurately into the LIS for one of four mislabeled patient samples reviewed from January and May 2026. Findings included: 1. Review of laboratory's computerized specimen problem logs from January and May 2026, revealed the following sample was marked as mislabeled due to mismatch in date of birth (DOB): Requisition number: 45148MB20 Sample: 260107-WM0015 Issue: Incorrect birthday on specimen Requisition form DOB: 03/03/1961 Specimen Container DOB: 3-3-1963 2. Review of Client Relations (CR) department's specimen resolution records revealed the CR obtained a copy of the chart from the provider to verify DOB for requisition number: 45148MB20, sample 260107-WM0015. The chart's DOB was documented as 03/03/1963. 3. Review of laboratory's final report for requisition number: 45148MB20, sample 260107-WM0015 revealed the report contained the wrong DOB, 03/03/1961. The laboratory's CR department failed to ensure correct DOB was input into the system after verification. 4. In an interview on 06/03/2026 at 1230 hours in the office, the laboratory's clinical supervisor confirmed the findings. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: A. Based on surveyor's observations, review of laboratory's policies/procedures, temperature records and staff interview, the laboratory failed to ensure sample storage temperature monitoring was documented for Refrigerator 5 and Freezer 6 for six of six months reviewed from January through June 2025. Findings included: 1. Surveyor's observations on 06/03/2026 at 1400 in the specimen processing area revealed samples were stored in Refrigerator 5 and Freezer 6, as indicated by labels on the devises. 2. Review of laboratory's policy "Clinical and Molecular Sample Acceptance Criteria" (document: ALTRU 08 DEPT, version 1.1, effective date: 04/29 /2026) revealed: "C. Appendix A: Clinical Samples Acceptable Devices, Shipment, Stability. ... Storage REF 2C-8C (degrees Celsius) 7 DAYS" 3. Review of laboratory's temperature records for refrigerators and freezers from January through June 2025 revealed there was no documentation of temperature monitoring for Refrigerator 5 and Freezer 6 for the six months reviewed. 4. In an interview on 06/03/2026 at 1500 hours in the clean desk area the laboratory's clinical supervisor stated that the frozen samples in Freezer 6 are for send-out to reference laboratory but confirmed that documentation of temperature recording for either Refrigerator 5 or Freezer 6 was not traceable, thus not available for review. B. Based on the direct observation of the surveyor, review of the temperature requirement from the vacutainer pack labels, the -- 3 of 6 -- laboratory's temperature logs, CMS 116, and confirmed in an interview, the laboratory failed to record temperature of the phlebotomy room Suite 120 that stores 3 of 3 types of vacutainers. The findings were: 1. Surveyor's direct observation on 06/03/26 at 10: 00am revealed a phlebotomy room, Suite 120, for walk-in patients and the room stored 3 types of vacutainers. BD Vacutainer Urinalysis Urine Tubes No Additive Lot#: 5260128 Exp. 2027-09-30 BD Vacutainer SST Blood Collection Tubes Lot#: 5272810 Exp. 2026-08-31 BD Vacutainer K2E 7.2 mg Blood Collection Tubes Lot#: 5225497 Exp. 2026-12-31 2. Review of the temperature requirement from the vacutainer pack labels revealed the temperature requirements for the above tubes were 4C to 25C. 3. Review of the laboratory's temperature logs revealed no temperature records or logs kept for phlebotomy room suite 120. 4. Review of the laboratory's CMS 116, signed by the laboratory director on 06/03/2026 electronically, revealed the annual volume for chemistry and hematology were 2,800,000. 5. An interview on 06 /03/2065 at 10:05 am in the clinical supervisor's office, the pre-analytical supervisor and the clinical supervisor confirmed the above findings. Key: C=Celsius CMS=Center for Medicare and Medicaid D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: A. Based on review of laboratory's and Client Relations (CR) department's policies /procedures/instructions, specimen problem logs, CR department's specimen resolution records, quality assurance (QA) records and staff interview, the laboratory's quality assurance (QA) failed have processes in place to ensure specimen problem resolution was documented by CR department as required for one of four sample problem categories reviewed, mislabeled samples. Findings included: 1. Review of laboratories policy "Accessioning SOP" [document: GENSOP 7 (version 5.0), effective 12/23/2025] revealed: "Mislabeled Form If a sample is received with only one identifier, a mislabeled form must be filled out ... client relations will contact the client to confirm the patient information." And, "Doctors Order Mismatch A Dr. Order Mismatch hold will be placed on samples that come with a doctor's order that does not match the panel selected on the requisition form. Client relations will then contact the client to confirm which panel needs to be performed." 2. Review of CR department's policies/procedures revealed: a. Policy "Rejection Notification SOP" (date updated: March 4, 2022) stated: " Invalid Label ... determine if the labeling issue is correctable. o If yes is marked, ask the client if they are familiar with how to correct through the portal- if yes, just remind them to have the collector make sure to provide the information that was not provided or wrong on the rejected sample. - Note: You can also e-mail the correction form ... - Once the form is returned to client relations follow these steps: Invalid Label Correction SOP" b. Policy "Invalid Label Correction SOP" (date updated: June 3, 2026) stated: "The purpose of this document is to describe the process of how to handle and update a sample once a completed invalid label correction form is received." And, "1. Review correction form to ensure it's accurately completed and is for a specimen eligible for correction. 2. Locate sample in LIS. 3. Upload completed form to LIS ... ... 6. Ensure all data entry is accurate based on req (requisition) form and name/DOB (date of birth) is accurate per correction form." 3. Review of the laboratory's "Mislabeled Specimen Correction Form" -- 4 of 6 -- revealed: "Labeling information on the specimen container and the request form must be identical and contain at least two unique identifiers (including FULL name and birthday). If a specimen is mislabeled, recollection of the specimen is highly recommended to eliminate any possible testing errors ... If the specimen cannot be recollected and or the client insists on analyzing the sample, they will be required to fill out this form below and return to Altru Diagnostics Lab." 4. Review of laboratory's computerized specimen problem logs from January and May 2026, revealed the following three samples were marked as mislabeled and were issued Mislabeled Specimen Correction Forms: Requisition number: 45148MB20 Sample 260107-WM0015 Requisition number: 44560MB833 Sample 260117-BM0416 and Requisition number: 26077KDC Sample 260520-YM0076 The forms had the section "TO BE COMPLETE BY THE CLIENT" and "Authorization in writing to run the sample using the corrected information ..." sections empty. 5. Review of the CR department's specimen resolution records and corresponding LIS records for the above mislabeled samples revealed there was no documentation of corrections completed by the client nor any "Authorization in writing to run the sample using the corrected information ..." as per requirements of the Mislabeled Specimen Correction Form. Further review of the information in the laboratory's LIS system provided by CR revealed the "Hold" was released, but there was no documentation or record (date/time /person contacted) of any communication with the client to obtain the correct information. 6. Review of laboratory's QA revealed the laboratory's QA did not identify or address process issues within the CR department and ensure proper documentation of CR department's activities regarding sample issues. 7. In an interview on 06/03/2026 at 1500 hours in the office the laboratory's clinical supervisor confirmed the findings. B. Based on the review of the laboratory's records, Client Relations (CR) records, CR communications with the laboratory, and confirmed in an interview, the laboratory's quality assurance failed to have processes in place to identify and correct issues with oral test requests for "Add On" tests having a follow up with written or electronic authorization requests. Refer to D5303. C. Based on review of laboratory's computerized specimen problem logs, Client Relations department's specimen problem resolution records, patient test records, quality assurance and staff interview, the laboratory's quality assurance failed to have processes in place to identify and correct issues with accurate patient information transcription into the Laboratory Information System. Refer to D5309. D. Based on surveyor's observations, review of laboratory's policies/procedures, temperature records, quality assurance and staff interview, the laboratory's quality assurance failed to have processes in place to identify and correct issues with sample storage temperature monitoring documentation. Refer to D5311. 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 laboratory and Client Relations (CR) department's policies /procedures/instructions, specimen problem logs, CR department's communication and specimen resolution records, sample storage conditions and test records, quality assurance (QA) records and staff interviews, the laboratory director failed to provide overall oversight and management of the laboratory for one of three phases of testing, -- 5 of 6 -- preanalytic systems. Findings included: 1. Laboratory director failed to ensure Laboratory director failed to ensure overall quality of preanalytic systems was maintained. Refer to D6082. 2. Laboratory director failed to ensure laboratory's quality assurance for preanalytic systems was established and maintained. Refer to D6093. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) (e) The laboratory director must-- (e)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on review of laboratory and Client Relations (CR) department's policies /procedures/instructions, specimen problem logs, CR department's communication and specimen resolution records, sample storage conditions and test records and staff interviews, the laboratory director failed to ensure Laboratory director failed to ensure overall quality of preanalytic systems was maintained. Refer to D5303, D5309 and D5311. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on review of laboratory and Client Relations (CR) department's policies /procedures/instructions, specimen problem logs, CR department's communication and specimen resolution records, sample storage conditions and test records, quality assurance (QA) records and staff interviews, the laboratory director failed to ensure laboratory's quality assurance for preanalytic systems was established and maintained. Refer to D5391A, B, C and D. -- 6 of 6 --

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted 09/16/2024 through 09/18 /2024. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of laboratory's proficiency testing (PT) records, PT agency's instructions, laboratory's policies/procedures and staff interview, the laboratory failed to ensure attestations were signed by laboratory director and/or technologist as required for five of eighteen reviewed PT events from 2023 and 2024. Findings included: 1. Review of laboratories proficiency testing records revealed the laboratory used the American Proficiency Institute (API) and the College of American Pathologists (CAP) as PT providers. 2. Review of PT agencies' instructions revealed: a. For API PT results - "For all PT results, attestation statement must be signed by testing personnel and the laboratory director and retained for a minimum of 2 years." b. For CAP PT results - "The laboratory director or designee and the testing personnel must sign on the result form. You may use the attestation page provided in the kit instructions or, alternatively, print, sign, and retain a copy of this page for your records and inspection purposes." 3. Review of the PT records for 2023 and 2024 revealed the following 5 of 18 reviewed PT events did not have the required signatures of either laboratory director and/or testing personnel: a. For the API events the following signatures were missing: 2024 Microbiology 1st Event was missing laboratory director's signature. 2024 Chemistry - Core 2nd event was missing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 16 -- laboratory director's signature. 2024 hematology coagulation 1st event was missing laboratory director's signature. b. For the CAP events the following signatures were missing: Event IDR-B 2023 (Infectious Disease, Respiratory Panel Survey) was missing laboratory director and testing personnel #3 signatures. Event COV2-A 2023 (SARS-CoV-2 Molecular Survey) was missing laboratory director's signature. 4 Review of laboratory's policy "SOP Proficiency Testing" (document SOP PT 011, version 3.1, last reviewed 12/27/2023) revealed: "5.1 CAP Proficiency Testing ... 6.) ... Attestation signatures from all testing personnel on the sample should be obtained." There were no protocols in place requiring laboratory director's signatures or protocols for signing attestation forms for the API PT samples. 5. In an interview on 09/16/2024 at 12:40 p.m. in the office, the laboratory's technical supervisor number 1 (as indicated on submitted form CMS 116) confirmed the findings. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of laboratory's proficiency testing (PT) records, PT agency's instructions, laboratory's policies/procedures and staff interview, the laboratory failed to ensure self-evaluation was documented for results that were "Not graded" or had "Note 26" for five of eighteen PT events reviewed from 2023 and 2024. Findings included: 1. Review of laboratories proficiency testing records revealed the laboratory used the American Proficiency Institute (API) and the College of American Pathologists (CAP) as PT providers. 2. Review of PT agencies' instructions revealed: a. For API: "Laboratories are responsible for documenting and performing

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the following CONDITION LEVEL DEFICIENCIES: D5300 - 42 C.F.R. 493.1240 Condition: Preanalytic systems Noted deficiencies and plans of correction were discussed with the laboratory representative (s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in this part. This STANDARD is not met as evidenced by: Unannounced revisit performed on 2/19/20 - 2/21/20: **New Deficiency Based on a review of the laboratory review of the laboratory's American Proficiency Institute proficiency testing records from 2019, and staff inte revealed that the laboratory failed to have documentation of reviewing and evaluating the proficiency testing 11 events in 2019. Findings include: 1. A review of the laboratory's policy titled 'Quality Assessment Plan' re following: "The laboratory will participate in qualified proficiency testing programs available for each specia the lab. The Medical Director will review all proficiency testing results." 2. Further review of the laboratory's Proficiency Institute proficiency testing records from 2019 revealed the laboratory failed to have documentat and evaluating the proficiency testing results for the following events: 2019 Hematology/Coagulation 2nd ev Immunology/Immunohematology 2nd event 3. An interview with technical consultant #1 (as indicated on the on 2/19/20 at 1:15 p.m. in the laboratory, after review of the records, confirmed the above findings. **************************************************************************************** D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testin does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonpartici return or results). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: An unannounced revisit was performed on 2/19/20 -2/21/20. **New Deficiency II. Based on review of the la College of American Pathologists (CAP) laboratory proficiency testing (PT) records, and confirmed in interv laboratory failed to verify the accuracy of the nonregulated analytes Influenza A Subtype, Parainfluenza, and 2019. Findings were: 1. Review of the laboratory policy Proficiency Testing Policy (Ver 1) in use 7/16/18 un and

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 a review of policies and procedures, the laboratory testing records, CMS 155 report, CMS 116 application and interview of facility personnel it was revealed that the laboratory failed to enroll in a proficiency testing program for each of the specialties and subspecialties for which it seeks certification. The laboratory performed patient testing in the specialties of Hematology (6 regulated analytes) and Chemistry; including the subspecialties of General Chemistry (22 regulated analytes) , Toxicology( 2 regulated analytes) and Endocrinology (6 regulated analytes). The findings included: 1. Review of the laboratory's policy titled Laboratory Proficiency Testing Policy dated 02/17/2018 found on page 1 under the heading POLICY - " In compliance with CLIA regulations, this lab will perform proficiency testing at least semi-annually on all required laboratory tests. Testing will be performed on a rotating basis by all staff." 2. A review of facility records found no documentation of the laboratory being enrolled in or participating in a CMS approved proficiency testing program for Hematology or Chemistry in 2018. The laboratory started testing patient specimens for Hematology, General Chemistry, Toxicology and Endocrinology procedures in July 2018. Regulated analytes tested by the laboratory were: Hematology WBC Differential Erythrocyte Count Mean Corpuscular Volume (MCV) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Hemoglobin Leukocyte Count Platelet Count General Chemistry Alanine Aminotransferase (ALT) Albumin Alkaline Phosphatase Amylase Aspartate Aminotransferase (AST) Bilirubin, total Calcium, total Chloride Cholesterol, total Cholesterol, HDL Creatine Kinase, total Creatinine Glucose Iron, total Lactate Dehydrogenase (LDH), total Magnesium Potassium Sodium Total Protein Triglycerides Urea Nitrogen Uric Acid Endocrinology Cortisol Free Thyroxine Human Chorionic Gonadotropin Triiodothyronine Thyroid Stimulating Hormone Thyroxine, total Toxicology Lithium Valproic Acid 3. Review of the CMS 155 report found no proficiency testing scores had been reported to the Centers for Medicare and Medicaid Services (CMS). 4. Documentation of enrollment in a proficiency testing program for each specialty and subspecialty was requested. Testing person 15 provided the enrollment form for proficiency testing in the 2018 College of American Pathologists (CAP) proficiency testing program for the Infectious disease respiratory panel. 5. Review of the CMS 116 application found that the laboratory recorded estimated volumes for each of the specialties: Hematology - 2000 Chemistry - 4000 6. Interview of testing person 15 listed on the CMS report 209 Laboratory Personnel Report conducted on November 28, 2018 at 2:07 PM confirmed that the laboratory did not enroll in, or participate in a proficiency testing program for the specialties of Hematology, Chemistry. He stated that he knew they were enrolled in proficiency testing for some tests, but not all. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Review of policies and procedures, proficiency testing records, patient test records, and interview of facility personnel found that the laboratory failed to follow their own Quality Assurance program for identifying monitoring and correcting problems in the general laboratory systems. The findings included: 1. Review of the laboratory's own policy titled Laboratory Quality Assessment Program dated 02/17/2018 found on page 2 under the heading INDICATORS OF QUALITY - "Quality indicators for this facility have been defined as, but not limited to: a. Personnel qualifications, training and performance evaluation b. Periodic evaluation of physical environment for safety and compliance. c. Communication and complaint investigation d. Evaluation of proficiency testing and split sample testing." Review of the laboratory's policy titled Laboratory Proficiency Testing Policy dated 02/17/2018 found on page 1 under the heading POLICY - " In compliance with CLIA regulations, this lab will perform proficiency testing at least semi-annually on all required laboratory tests. Testing will be performed on a rotating basis by all staff." 2. A review of facility records found no documentation of the laboratory being enrolled in or participating in a CMS approved proficiency testing program for Hematology or Chemistry in 2018. The laboratory started testing patient specimens for Hematology, General Chemistry, Toxicology and Endocrinology procedures in July 2018. 3. Review of the CMS 155 report found no proficiency testing scores had been reported to the Centers for Medicare and Medicaid Services (CMS). 4. Documentation of enrollment in a proficiency testing program for each specialty and subspecialty was requested. Testing person 15 provided the enrollment form for proficiency testing in the 2018 College of American Pathologists -- 2 of 6 -- (CAP) proficiency testing program for the Infectious disease respiratory panel. 5. Interview of testing person 15 listed on the CMS report 209 Laboratory Personnel Report conducted on November 28, 2018 at 2:07 PM confirmed that the laboratory did not enroll in, or participate in a proficiency testing program for the specialties of Hematology, Chemistry. He stated that he knew they were enrolled in proficiency testing for some tests, but not all. 2. Review of proficiency testing records found no documentation of enrollment in a proficiency testing program for each specialty and subspecialty tested. D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Review of the operator ' s manual, laboratory policies and procedures, and interview of facility personnel found that the laboratory failed to have a policy for handling flagged results obtained on patient CBC (complete blood count) results when using the Coulter AcT 5 diff hematology analyzer. The laboratory also failed to establish and define a frequency of calibration procedures. Findings included: A. Handling of Flagged results obtained on CBC results 1. Review of the operator ' s manual found: a. on page 9-34 under the heading REVIEWING RESULTS - "Carefully review all parameter results, especially results with flags and/or messages . Verify flagged results for accuracy and review any result that exceeds your laboratory's limits." 2. Review of the laboratory's policies and procedures found no written instruction for handling flagged results obtained on patient CBC results. 3. Interview of testing person 4 on the CMS report 209 Laboratory personnel report confirmed that there was no additional written policy available to testing personnel defining actions to be taken when flagged results occur. B. Calibration and Calibration verification procedures Based on review of the operator's manual, calibration records, and staff interview, the laboratory failed to establish and define the frequency of calibration and or calibration verification procedures for the Coulter ACT 5 diff hematology analyzer. The findings include: 1. Review of the Coulter AcT5 diff hematology analyzer operators manual found on page 10-1 When to Calibrate - "Calibrate your instrument: During installation After a Beckman Coulter service representative has replaced an analytical component. as instructed by a Beckman Coulter representative." Further review found under the heading When to Verify Calibration - "Verify calibration of your instrument: As required by your laboratory procedures, and as required by local or national regulations. When cell controls, such as AcT 5diff Control Plus, exceeds the manufacturer's defined acceptable limits" 2. Review of policies and procedures found that the laboratory did not have a policy defining the frequency of calibration and or calibration verification of the Coulter AcT 5 diff hematology analyzer. 3. Review of calibration log from 2018 found that the laboratory calibrated the Coulter AcT 5 diff hematology analyzer: January 22, 2018 (installation) January 23, 2018 March 8, 2018 April 13, 2018 May 11, 2018 June 16, 2018 July 11, 2018 September 6, 2018 September 27, 2018 October 19, 2018 October 23, 2018 November 9, 2018 4. Interview of the testing person 4 on the CMS report 209 conducted on November 28, -- 3 of 6 -- 2018 at 3:29 PM confirmed that the laboratory did not have a written policy defining the frequency of calibration for the Coulter AcT 5diff. he stated that he " calibrates the analyzer with each new lot of Quality control material D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview of facility personnel the laboratory director failed to ensure the laboratory was enrolled in a proficiency testing program for the specialties of Hematology and Chemistry ( including the subspecialties of general chemistry, endocrinology and toxicology. ( see D 2000) D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: An unannounced revisit was performed on 11/27/18 - 11/30/18. Based on review of the laboratory records, patient records, and confirmed in interview, the laboratory director failed to ensure the laboratory provided quality laboratory services for all aspectes of test performance. Refer to D5311, D5469 D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: An unannounced revisit was performed on 11/27/18 - 11/30/18. Based on a review of the Laboratory Personnel Report, personnel records and staff interview, it was revealed that 8 of 13 testing personnel performing high complexity testing did not have the appropriate education credentials required to perform high complexity testing (refer to D6171). D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) -- 4 of 6 -- (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. -- 5 of 6 -- This STANDARD is not met as evidenced by: An unannounced revisit was performed on 11/27/18 - 11/30/18. Based on a review of personnel files and interview of facility personnel it was revealed that the facility failed to provide documentation of education credentials to quality all testing personnel to perform high complexity testing at the end of the survey on 11/30/18. Findings were: 1. A review of facility personnel files revealed that 8 of 13 testing personnel failed to have appropriate educational documentation available for review at the time of the survey to qualify them to perform high complexity testing. Testing Person #1, hire date 3/12/18 Testing Person #12, hire date 2/15/18 Testing Person #13, hire date 7/19/18 Testing Person #8, hire date 11/14/18 Testing Person #9, hire date 11/19/18 Testing Person #5, hire date 3/1/18 Testing Person #4, hire date 7/30/18 Testing Person #7, hire date 10/8/18 2. An interview of the testing person #12 on 11/30 /2018 at 1125 hours in the break room confirmed the above findings. -- 6 of 6 --