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Summary Statement of Deficiencies D0000 A complaint survey for 2022003587 was conducted on 4/20/2022 to 4/21/2022 at American Health Associates. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 An unannounced complaint survey for 2021007526, was conducted on 6/16/2021 to 6 /17/2021 at American Health Associates. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to have a biological specimen refrigerator in the drawing room to ensure urine specimens are not placed in a refrigerator used for employee food storage. Findings included: An observation of drawing station on 6/16/2021 at 9:00 AM revealed that the room had one refrigerator. The refrigerator had ice buildup and was used to store food inside and was not labeled for biological specimen use. A review of Urine Culture procedure stated "transportation of urine to the laboratory after or if collection cannot not be deliver to the laboratory within 2 hours after of collection refrigerate up to 24 hrs. If the urine culture tube is used, the urine specimen is viable for culture up to 72 hours." During an interview on 6/16/2021 at 9:30 AM, the drawing station technician confirmed there was only one unlabeled refrigerator in the room. They stated a courier picks up only stat samples and the other courier picks specimen up after 5 PM to deliver to the laboratory daily. D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all 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 -- phases of the total testing process that are under the laboratory's control. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to ensure the privacy of patient records in the drawing room. Findings included: An observation of drawing station on 6/16/2021 at 9:30 AM displayed a stack of patient's requisitions in a box with names, addresses, birth dates and social security numbers were kept in a corner by an opened door by the waiting room. The open door is the only entrance into the drawing station from the waiting room. Review of General Overview of Health Insurance Portability and Accountability Act (HIPPA) revealed "Any facility with a patient service center have designated patient entrances that are locked and unlocked during normal operating hours by authorized employee. The patients are escorted to and from the drawing room by phlebotomist." During an interview on 6/16 /2021 at 9:30 AM with the drawing technician, they confirmed the stack of patient information in a box by the door that led to the waiting room. 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, the laboratory failed to have a written policy for complaints in the laboratory. The laboratory failed to document the canceled urine specimen sent to reference laboratory in a complaint log. Findings included: Review of patient urine records displayed a urine specimen collection issue with a canceled urine test from a reference laboratory in 4/08/2021. Review of general laboratory procedure revealed no written policy for complaints made in the laboratory. Review of complaint log revealed no written documentation for urine test canceled on 4/08 /2021 from reference laboratory. During an interview on 6/17/2021 at 5:26 PM, the owner and laboratory consultant confirmed no written complaint policy and documentation of canceled urine test from a reference laboratory. D5393 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(b)(c) The preanalytic systems assessment must include a review of the effectiveness of

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 observation, record review, and interview, the laboratory failed to label the quality control vials currently in use with the open and expiration dates. Findings Included: Examination of the Beckman Coulter 6C Cell Controls and 6C Retic Controls for the Beckman Coulter DxH 900 hematology analyzer on 05/04/2021 at 1: 50 PM showed the quality control vials for level 1, 2 and 3 did not have the open date and the new expiration date for the vials currently being used. Review of the package insert for the controls noted the controls are good for 16 days once they have been opened. During an interview 05/04/2021 at 1:5430 AM, Testing Personnel H stated the open date and the new expiration date were not on the control vials. 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 An announced recertification survey was conducted on 02/08/2021 to 02/22/2021 at American Health Associates. The laboratory was not in compliance with 42 CFR 493, Requirements for Clinical Laboratories. Based on the survey findings, an Immediate Jeopardy situation was identified and the laboratory was notified at 2:45 PM on 02/19 /2021. The laboratory failed to follow manufacturers' instructions (MI) for storing Ammonia quality control and patient specimens, failed to run quality control per MI, failed to monitor COVID 19 pooled specimens, and failed to validate instruments prior to reporting patients (See D5300 and D5400). The following Conditions were not met: D5300 - Preanalytic Systems 493.1240 D5400 - Analytic Systems 493.1250 D6141 - General Supervisor 493.1459 D6168 - Testing Personnel 493.1487 D6076 - Laboratory Director 493.1441 D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on record review, observation and interview, the laboratory failed to have a closed uni-directional flow system for their molecular COVID-19 PCR(Polymerase Chain Reaction) testing as of 2/22/2021. Finding included: During an observation on 02/12/2021 at 11:00 AM, a molecular technologist held a 96 well plate and walked through an Accession room for microbiology, blood cultures and urine and then walked into the PCR reading room to test the 96 well plate. Review of Molecular Testing Diagram revealed that molecular technologists have to go across an accessioning room to reach the PCR reading room. Review of Lyra Direct SARS- CoV-2 Assay package insert states, "Proper workflow planning is essential to minimize contamination risk. Always plan laboratory workflow in a uni-directional Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 20 -- manner, beginning with pre-amplification and moving through amplification and detection." During an interview on 2/22/2021 at 6:00 PM, the molecular supervisor confirmed no uni-directional flow existed for molecular technologists to pass through an accessioning area with COVID-19 and 96 well plates to reach the PCR reading room. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observations, record review, and interview with the Laboratory Manager, the laboratory failed to properly use the flammable cabinet, and failed to store 1 gallon of 100% alcohol and 12 gallons of Methyl alcohol in a flammable cabinet. Findings Included: Observation taken on tour that was conducted on 02/08/2021 at 1: 45 PM revealed, multiple papers and folders stored on the top shelf of the flammable cabinet. In the Microbiology department a 1 gallon container of 100% alcohol was observed sitting on a shelf. In the storage room 3 boxes with 4 - 1 gallon containers of Methyl alcohol was observed stacked against a shelf. Review of the Safety Data Sheet revealed, both the 100% alcohol and the Methyl alcohol were to be stored in an approved Flammable Liquids storage area. During an interview on 02/08/2021 at 2:30 PM, the Laboratory Manager confirmed that the containers of alcohol were supposed to be stored in the flammable cabinet and the papers should not have been put in the flammable cabinet. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain calibration records for at least two years. Findings included: Review of the procedure titled, "Record Retention Policy" signed and dated by the Laboratory Director on 08/11 /2020, noted the Calibration and Calibration verification records, and Equipment maintenance and function check records be retained for two years. 1. The laboratory has three Beckman Coulter DXH900 hematology instruments that were validated in January 2020. Review of the calibration records for the DXH900 hematology instruments showed that the instrument print outs for the calibration performed on 07 /07/2020 were missing for the hematology instrument S/N BC50900. During an interview on 02/09/2021 at 1:51 PM, the General Supervisor - C stated, she was unable to locate the missing instrument printouts. 2. The laboratory used two Beckman Coulter DXH800 hematology instruments in 2019. Review of the calibration records for the DXH800 hematology instruments were not available for review. During an interview on 02/10/2021 at 4:10 PM, the General Supervisor - C stated, she was unable to locate the missing calibration record for the DXH800 used in -- 2 of 20 -- 2019. 3. Review of the maintenance for the Arkray Aution Max AX-4030 instruments used for urine chemistry testing showed the maintenance from 01/01/2020 to 08/31 /2020 was not available for review at the time of the survey. During an interview on 02 /13/2021 at 12:50 PM, the General Supervisor - C stated, the maintenance records were missing. D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) In addition, the laboratory must retain records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to maintain the raw data used for their IQCP (Individualized Quality Control Plan) on Microbiology plates. Findings Included: Review of the IQCP for Microbiology plates revealed, no raw data that was used for the Quality Control part. The IQCP was originally established 10/11 /16 and was last signed by the Laboratory Director on 08/11/20. Interview on 02/12 /21 at 4:00 PM with the Microbiology Supervisor confirmed, the raw data was not available. 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 staff interview, the laboratory failed to perform competency assessment for 2 (TP 1 and 2) out of 21 (TP 1 to TP 21) testing personnel (TP) and did not follow the Employee Competency policy for 2 out of 2 years reviewed (2019-2020). Findings included: 1) Review of the Personnel Policy revealed, the policy failed to include that when Supervisors also have the role as testing personnel they are required to have a competency assessment as TP. 2) Review of the CMS 209 Laboratory Personnel Report dated and signed by the Laboratory Director (LD) on 02/09/2021 revealed, there were 22 TP. TP 1 and 2 also are GS (General Supervisors). During an interview on 02/09/2021 at 11:30 AM, with GS 1, she confirmed that the laboratory failed to perform competency assessment for the TP of reference. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have a policy to -- 3 of 20 -- perform the accuracy verification study on the primary method for testing SARS COVID 19 RT PCR (Severe Acute Respiratory Syndrome Coronavirus Disease 2019 Real Time Polymerase Chain Reaction) patients since 7/1/2020. Findings included: Review of Policy Number 6-102.15M for proficiency testing (PT) revealed, the laboratory failed to define that the PT is required for only the primary method for patient testing. Record review revealed, the laboratory has been running COVID 19 patient testing with the Lyra method since 07/01/2020. Review of the College of American Pathologists (CAP) revealed, the laboratory performed the PT for the Taq- Path COVID 19. This method is not the method used in the daily patient testing. Review of a comparative sample study performed in December 2020 for the COVID 19 Lyra method revealed, the laboratory did not have the raw data for the 2 laboratories involved to support their results. During an interview on 02/08/21 at 2:30 PM, the General Supervisor confirmed, the laboratory failed to have a policy to perform accuracy verification for the COVID 19 Lyra method since 07/01/2020. 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: 42115 Based on observation, record review and interview, the laboratory failed to ensure the test requisitions are received from an authorized person for 1 (#2) out of 6 (#1, #2, #3, #4, #5, & #6) test requisitions. The laboratory failed to ensure 10 out of 10 (C-1, C-2, C-3, C-4, C-5, C-6, C-7, C-8, C-9, & C-10) chemistry test requisitions were signed by an authorized person (See D5301). The laboratory failed to ensure the test requisitions solicits the time of collection (See D5305), failed to follow their policy to ensure temperatures of COVID-19(Coronavirus 2019) specimen delivered on 2/10/2021 for the Lyra Direct SARS-COV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) Assay were in acceptable ranges for testing; Failed to ensure the stability of Ammonia samples since 02/2019 (See D5311); and Failed to document collection dates and times for 4 out 4 COVID-19 patients tested for Lyra Direct SARS- CoV-2 Assay. (See D5313). D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure the complete blood count with differential test requisitions for 1 (#2) out of 6 (#1, #2, #3, #4, #5, #6) are received from an authorized person and failed to ensure 10 out of 10 (C-1, C- 2, C-3, C-4, C-5, C-6, C-7, C-8, C-9, and C-10) chemistry test requisitions were signed by an authorized person. Findings Included: Review of test requisitions for -- 4 of 20 -- hematology patients showed that 1 (#2) out of 6 (#1, #2, #3, #4, #5, #6) failed to include the name of the physician who ordered the complete blood count with differential. Review of test requisitions for chemistry patients showed that 10 out of 10 (C-1, C-2, C-3, C-4, C-5, C-6, C-7, C-8, C-9, and C-10) chemistry test requisitions were not signed by an authorized person. During an interview on 02/10/19 at 2:40 PM, the General Supervisor - C stated, the test requisition didn't provide the ordering physician's name for the complete blood count with differential patients and did not have an authorized signature on the test requisition for the chemistry tests. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure the test requisitions solicits the time of collection. Findings Included: Review of Test requisitions for Hematology patients showed that 2 (#5, #6) out of 6 (#1, #2, #3, #4, #5, #6) failed to include the collection time. Review of Test requisitions for Coagulation patients showed that 5 (#1, #2, #3, #4, #11) out of 11 (#1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11) failed to include the collection time. Review of Test requisitions for Urinalysis patients showed that 1 (#6) out of 6 (#1, #2, #3, #4, #5, #6) failed to include the collection time. During an interview on 02/12/21 at 4:30 PM, the General Supervisor - C stated, the missing collection times were across the board in all areas of testing. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to follow their policy to ensure temperatures of COVID-19 (Coronavirus 2019) specimen -- 5 of 20 -- delivered on 2/10/2021 for the Lyra Direct SARS-COV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) Assay were in acceptable ranges for testing and failed to ensure the stability of Ammonia samples since 02/2019. Findings Included: During an observation on 2/10/2021 at 2:25 pm, a courier brought in a COVID-19 specimen in a plastic bag without documention of temperature or collection dates. Then the accessioning technician measured the temperature of the plastic bag of the specimen with a laser temperature gauge and recorded that as the constant temperature of the COVID-19 specimen. Review of the Lyra Direct SARS-CoV-2 Assay package insert states, "Nasal, nasopharyngeal, or oropharyngeal swab specimens should be collected and placed in a clean, dry transport tube. Specimens should be transported and tested as soon as possible after collection. Specimens are stable for up to 48-hours at room temperature or up to 72-hours when stored at 2(C) Celsius to 8C. If specimens cannot be tested within 72 hours of collection, they should be frozen at -70C or colder until tested. Stability at-70C was assessed up to 8 days from collection." Review of COVID-19 Testing Protocol (dated 12/06/2020) states, once collected, specimens must be refrigerated and subsequently transported in a thermal cooler to maintain temperature between 2 and 8 degrees C. During an interview on 2/10/2021 at 2:25 pm, the accessioning technician confirmed, the temperatures of the COVID-19 specimen in the plastic bag were not monitored before arrival. Observations during a tour of the accession area at 1:45 PM on 02/08/2021 revealed, Ammonia samples were stored in a frost free freezer until tested. Review of the policy and procedure manual (Last reviewed by the Lab Director on 09/23/2020) revealed, Ammonia specimens were stable for 3 hours at 2-8 degrees Celsius and stable for 24 hours when frozen less than or equal to - 20 degrees Celsius. Review of the temperature charts for the freezer where the Ammonia samples were stored prior to testing from 02/2019 until 02/2021 revealed, no temperature less than or equal to -20 degrees Celsius. Interview with the Laboratory Manager on 02/08/2021 at 2:00 PM confirmed, the freezer was used to store Ammonia specimens until tested. There were 1,661 Ammonia samples tested in 2019; 2,090 tested in 2020; and 231 tested in 2021. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on observation, record review, and interview revealed that the laboratory failed to follow their policy to document collection dates and times for 4 out 4 COVID-19 (Coronavirus 2019) patients tested for Lyra Direct SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) Assay. Findings Included: A Review of COVID-19 Patient Record revealed, 4 (26957803, 26956292, 26956294, and 26956295) out 4 patients requisitions had no collection date and time and order date and time. Review of the Lyra Direct SARS-CoV-2 Assay package insert states, "Nasal, nasopharyngeal, or oropharyngeal swab specimens should be collected and placed in a clean, dry transport tube. Specimens should be transported and tested as soon as possible after collection. Specimens are stable for up to 48-hours at room temperature or up to 72-hours when stored at 2C to 8C. If specimens cannot be tested within 72 hours of collection, they should be frozen at -70C or colder until tested. Stability at-70C was assessed up to 8 days from collection." During an observation on 2/10/2021 at 2:25 pm, an accessioning technician placed a collection date of 2/10 /2021 in the accessioning system for 4 (26957803, 26956292, 26956294, and 26956295) out 4 patients requisitions without collection dates and times. Review of -- 6 of 20 -- the COVID-19 Collection Policy (signed by the Laboratory Director 12/06/2020) states, we must have the patient full name, collection date and time on every requisition and sample. Failure to provide this information can and will result in your specimen being rejected. During an interview on 2/10/2021 at 2:25pm with the Accessioning Technician confirmed, the laboratory failed to document the collection date and time of 4 out 4 COVID-19 patients tested for Lyra Direct SARS-CoV-2 Assay. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: 42115 Based on record review and interview, the laboratory failed to have policies that reflected what was being performed in Microbiology and did not have a policy on how to contact providers when a redraw was necessary (See D5403). Based on record review, observation and interview, the laboratory failed to have a COVID-19 pooling policy for mixing several COVID-19 (Coronavirus 2019) samples together in a batch or pooled sample, then testing the pooled COVID-19 samples with a Lyra Direct SARS-COV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) Assay and TaqPath COVID-19 Combo Kit as of 1/1/2021 to 2/11/2021 and failed to store Ammonia controls per the manufacturer's instructions since 02/2019 (See D5411). Based on record review and interview, the laboratory failed to perform a validation of the iQ Series Automated Urinalysis System and the Iris iChem Velocity instruments. (See D5421) Based on record review and staff interview, the laboratory failed to complete a validation for the Sofia 2 SARS Antigen and Sofia 2 Flu + SARS Antigen FIA for uses of an unauthorized nasal swabs before testing from 9/7/2020 to present. The laboratory failed to complete a validation for Lyra Direct SARS-CoV-2 Assay and TaqPath COVID-19 Combo Kit from before testing from 6/3/2020 to present. The laboratory failed to complete a validation for the use of the Applied Biosystems COVID 19 Interpretive Software with Lyra Direct SARS-CoV-2 Assay before testing from 6/25/2020 to present. (See D5423) Based on record review and interview, the laboratory failed to document the maintenance performed on the Beckman Coulter DXH900 hematology instruments, the Sysmex CS-2500 coagulation instruments, and the iQ Series Automated Urinalysis System and the Iris iChem Velocity instruments. (See D5429) Based on record review and interview, the laboratory failed to follow manufacturer's instructions by not performing calibrations on the Arkray Aution Max AX-4030 urine chemistry analyzer monthly from 01/01/20 to 02/28/21. (See D5437) Based on observation, record review and interview, the laboratory failed to establish documentation and monitoring of external quality control(QC) for the unvalidated high complexity use of Sofia 2 Flu + SARS Antigen and Sofia 2 Flu + SARS Antigen from 9/7/2020 to present. (See D5441) Based on record review and interview, the laboratory failed to perform quality control per the laboratory's IQCP (Individualized Quality Control Plan) on 5 out of 5 Labpro Microscan Walkaway Microbiology instruments, and failed to perform quality control daily when in use on the Autoscan Walkaway instrument for 2 of 2 years (02/2019-02/2021) reviewed (See D5445). -- 7 of 20 -- Based on record review and interview, the laboratory failed to perform quality control lot to lot comparisons from 02/08/2019 to 02/08/21 for hematology controls. (See D5469) Based on record review and interview the laboratory failed to document the physical characteristics of the media for 2 out of 2 (02/2019-02/2021) years reviewed (See D5477). Based on record review and interview, the laboratory reported patients without 2 levels of controls being acceptable for 13 days (01/05/21, 11/13/20, 10/21 /20, 04/05/20, 03/09/20, 03/21/20, 12/14/19, 07/07/19, 07/11/19, 06/27/19, 06/02/19, 06/01/19, and 02/23/19) for Hemoglobin A1C, 1 day (06/23/19) for Free T4, 1 day (09 /16/20) for Creatinine, 3 days for Vitamin D (09/22/20, 09/23/20, and 09/24/20), and 2 days for Ammonia (09/24/20 and 09/25/20) (See D5481). Based on record review and interview, the laboratory failed to have a system that twice a year evaluates and defines the relationship between test results using the different methodologies and instruments (See D5775). Based on record review and interview, the laboratory failed to ensure accurate and reliable tests results for 1 (#8) out of 11 (#1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11) coagulation patients (See D5779). D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform quality control per the laboratory's IQCP (Individualized Quality Control Plan) on 5 out of 5 Labpro Microscan Walkaway Microbiology instruments, and failed to perform quality control daily when in use on the Autoscan Walkaway instrument for 2 of 2 years (02/2019-02 /2021) reviewed. Findings Included: Review of Manufacturer's instructions on all 6 Walkaway instruments revealed, quality control can be ran weekly when an IQCP is developed. An IQCP was developed for the 5 Labpro Microscan Walkaway instruments that stated quality control would be ran weekly. No IQCP was developed for the Autoscan Walkaway instrument. Review of quality control for September 2020 revealed, that each of the 6 Walkaway instruments only had quality control performed once a month (Labpro 1A-09/24/20, Labpro 2A-09/30/20, Labpro 2B-09/02/20, Labpro 3A-09/10/20, Labpro 3B-09/08/20, and Autoscan 09/24/20). Interview on 02 /13/21 at 11:45 AM with the Microbiology Supervisor revealed, she was told to alternate the weeks for quality control on the machine. She confirmed that they were not following their IQCP. Performing a rotating quality control was not included in the laboratory's IQCP. There were no manufacturers instructions provided to support rotating quality control. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. -- 8 of 20 -- (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 An unannounced complaint survey (#2020013583) conducted on 9/23/2020 - 9/25 /2020, found that American Health Associates clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following Conditions were not met : 5300-Preanalytic Systems 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 observation, record review and interview, the laboratory failed to follow Quidel Lyra Direct SARS-CoV-2 RT - PCR manufacturer's storage and rejection procedures for COVID-19 specimen testing from July 20, 2020 to Sept. 23rd 2020. (see 5311) D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed follow Quidel Lyra Direct SARS-CoV-2 RT - PCR manufacturer's storage and rejection procedures for COVID-19 specimen testing from 7/20/2020 to 9/23/2020. Findings Included: Review of Quidel Lyra Direct SARS-CoV-2 RT - PCR Assay manual revealed COVID-19 specimen are stable for up to 24 hours at room temperature or up to 72 - hours when stored at 2 degree Celsius (C) to 8 C. If specimens cannot be tested within 72 hours of collection, they should be stored at -70 C or colder until tested. Review of COVID-19 Testing Protocol stated once collected COVID-19 specimens must be refrigerated and subsequently transported in a thermal cooler to maintain temperature between 2 C and 8 C. Review COVID-19 specimen rejection policy revealed no rejection log for COVID-19 specimen not stored properly at room temperature at 24 hours, 2 C to 8 C at 72 hours or -70 C after 72 hours. Based on Observation of the COVID-19 specimen receiving area revealed COVID -19 specimen sitting in boxes at room temperate without a time log indicating 24 hours. There was no thermometer in shipping boxes to indicate if the COVID-19 specimen were at 2-8 C during transportation. COVID-19 specimen for retest were stored in a refrigerator at 6.7 C. Shipping boxes with COVID-19 specimen are place in refrigerator without review of collection time. A review of Patients requisitions revealed Patients: 26316352,26316354 ,26316358, 26316357, 26316362 had a collection date of 7/15/20 and receiving date of 7/20/20. There was no documentation of patient samples being store in a -70C after 72 hours. A review of COVID-19 Patients log revealed 146,532 patients have been tested for COVID-19 RT-PCR from 7 /20/2020 to 9/23/2020. During an interview on 9-24-2020at 9:30 am , the supply manager confirmed specimen were received in a shipping box without a temperature gauge, COVID-19 specimen were kept in a refrigerator with a temperature of 6.7 degrees C and bins without review of collection dates and time frames . D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory performed Quidel Lyra Direct SARS-CoV-2 RT-PCR testing on 5 (26394877, a3875663, a3875667 ,26316343, 26316339) out of 5 patient requisitions no collection date and time for COVID-19 specimen in 7/20/2020, 8/21/2020 and 8/22/2020. Finding Included: Review of Quidel Lyra Direct SARS-CoV-2 RT - PCR Assay manual revealed COVID-19 specimen are stable for up to 24 hours at room temperature or up to 72 - hours when stored at 2 degree Celsius (C) to 8 C. If specimens cannot be tested within 72 hours of collection, they should be stored at -70C or colder until tested. A review of Patients requisitions revealed 5 (26394877, a3875663, a3875667, 26316343, 26316339) out of 5 patients had COVID-19 specimen no collection dates and time in 7/20/2020, 8/21/2020 and 8 /22/2020. A review of final reports revealed the lab had placed their own collection times and dates for patients: 26394877, a3875663, a3875667,26316343, 26316339. During an interview on 9/25/2020 at 10:00am, the co-owner, general manager and lab manager confirmed collection dates and time were missing from 5 out 5 patient requisitions in 7/20/2020, 8/21/2020 and 8/22/2020. -- 2 of 4 -- D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to have logs identifying temperature ranges for refrigerators, freezers and room temperatures for COVID- 19 testing in molecular room from 6/28/2020 to 9/23/2020. Findings Included: Review of Quidel Lyra Direct SARS-CoV-2 RT- PCR Assay manual revealed PCR procedures need to be run at a controlled room temperature of 20 degree Celsius (C) to 25 C . Review of Temperature Room logs revealed no room temperature readings for molecular rooms from 6/28/2020 to 9/23/2020. Observation of Molecular room revealed no thermometer to record room temperature. Review of Freezers and Refrigerators temperature logs revealed freezers and refrigerators had no temperature ranges to identify the equipment was in or out of range and where it was located . Review of Freezer and Fridge manual revealed no manuals were available for review onsite. During an interview on 9-25-2020 at 10:00 am, the molecular supervisor confirmed no logs identifying the ranges temperature of for fridges and freezers and recording room temperature for COVID- 19 testing in molecular areas from 6/28/2020 to 9/23/2020. 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 observation, record review and interview, the laboratory failed to store Tag Man Open Array Urinary Tract kit and Fast 96 - well Region of Interest Background plates according to manufacturer's guidelines. Findings Included: An observation of Molecular Reading room revealed an ultra - low freezer with a set temperature of -70 degrees Celsius (C). Located in the freezer were Tag Man Open Array Urinary Tract kit and Fast 96 - well Region of Interest. Fast 96 - well region of interest background plates and Tag Man Open Array Urinary Tract kit storage temperatures are -15 C to -25 C. Review of the ultra-freezer temperature logs revealed the freezer temperature at -70 C. During an interview on 9-25-2020 at 10 am, the molecular supervisor confirmed reagents and plates were stored in a freezer below the manufacturer's storage requirements. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE -- 3 of 4 -- CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to validate threshold changes from 10,000 to 1,000 as acceptable for negative, positive and inconclusive results for COVID-19 patients for the Quidel Lyra Direct SARS-CoV-2 RT - PCR Assay from July 24,2020 to Sept 18th, 2020. Findings Included: Review of Quidel Lyra Direct Assay Verification Study revealed 10,000 threshold was used indicated if Covid-19 specimen were negative, positive or inconclusive . Review of Quidel Lyra Direct SARS-CoV-2 RT - PCR machine printouts displayed threshold changes from 10,000 to 1,000 from July 24, 2020 to Sept 18th, 2020. Review of COVID-19 Quidel Lyra PCR Patient Results showed a3875667 and a3875663 patients tested for PCR on August 22, 2020 with a threshold of 10,000 and resulted in two inconclusive results. The two patients samples were re-run with a threshold of 1,000 and both recieved negative results. During an interview on 9-25-2020 at 10am, the molecular supervisor confirmed threshold changes had been made for COVID-19 Quidel Lyra Direct Assay kit and was not validated. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory director (LD) failed to ensure the validations and procedures for COVID-19 were approved and signed. Findings Included: Review of Quidel Lyra Direct Assay Verification Study For SARS-CoV-2 revealed the LD did not sign validation. Review Quidel Lyra Assay Bringing Study for Qualitative Detection of Verification Study For SARS-CoV-2 revealed no signature from LD. Review of COVID-19 procedure revealed LD had not signed the document . During an interview on 9-25-2020 at 10am, the molecular supervisor confirmed LD did not sign the validations and procedures for COVID-19. -- 4 of 4 --

Summary Statement of Deficiencies D0000 An unannounced complaint survey, #2019010050, was conducted on 7/22/2019 at American Health Associates. The facility was not in compliance with 42 CFR 493, Requirement for clinical laboratories. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory did not follow their policy and procedure for "Problem/Redraw Procedure". Findings include: -Review of "Problem/Redraw Procedure" revealed that for specimens with an accession number (after a specimen registration into the laboratory software a unique number is generated) that have pending tests, it is required a redraw. This policy and procedure require a code 667 (problem report) generated and a note added to the case of reference. The note should have the information of the notification to the ordering facility with name of the notified nurse, date and time, after this notification the laboratory should proceed to cancel the test. A redraw log is kept as part of this procedure. -Review of Missed Routine and redraw log and Failed log for May, June and July 2019, revealed 1 case with accession number 25791265 (on 6/5/2019), as recorded in the log, there was not enough amount of urine sample to perform the urine culture test. The lab did not generate a 667 code and the problem was not reported to ordering facility but the laboratory canceled the test. The case on the end user side still showed as pending on 7/23/2019. -Review of Urinalysis, June cases revealed a 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 -- case with accession number 25751454 (on 6/17/2019), and final report on 6/24/2019, which stated no urine culture was performed due to an accident, but it was not reflected in the redraw log, no 667-code was generated, despite test being cancelled on 6/18/2019, and there was no notification to the ordering facility until 6/24/2019. Due to the fact that both cases lacked code 667, no problem report generated and they were not detected as pending tests. During an interview on 7/23/2019 at 2:00 pm, with Technical Supervisor, she confirmed the laboratory failed to follow their policy for Problem/Redraw Procedure for the cases of reference and the lack of documentation of the sample incident for case 25751454. D5815 TEST REPORT CFR(s): 493.1291(h) When the laboratory cannot report patient test results within its established time frames, the laboratory must determine, based on the urgency of the patient test(s) requested, the need to notify the appropriate individual(s) of the delayed testing. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory failed to notify of a delay in patient result to the ordering facility for 2 cases during June 2019. Findings include: Review of Turnaround reports for urine culture test revealed a turnaround time of 48 hours for test results (as per case 25735291, 2573426, 25734924, 25741515, 257429973). Review of case 25791265, revealed, test cancelation due to not enough sample and no notification sent to the facility. Review of case 25751454, revealed, test cancelation on 6/18/2019 due to a sample issue not properly documented and a delayed in the contact to the ordering facility until 6/24 /2019. During an interview on 7/23/2019 at 2:00 pm, with Technical Supervisor, she confirmed the laboratory failed to notify the ordering facility about the issues with pending urine culture after they passed their turnaround time . -- 2 of 2 --

Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(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: Based on record review of College of American Pathologist (CAP) proficiency testing records and interview with Technical Supervisor (TS), the laboratory failed to get at least 80 % for 1 (2nd event of 2018) out of 6 events for Bacteriology. Findings include: Review of CAP proficiency records for 2017 and 2018 revealed that the laboratory had unacceptable results for 2 out of 5 bacterial identification samples receiving a score of 60 % and resulting in an overall score of 73 % in Bacteriology 2nd event of 2018. During an interview on 02/13/2019 at 3:30 PM, the TS confirmed that the laboratory failed the event of reference. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review of College of American Pathologist (CAP) proficiency testing records and interview with Technical Supervisor (TS), the laboratory failed to score at least 80 % on Creatine Kinase (CK) for 1 (3rd event of 2017) out of 6 events for Routine Chemistry reviewed. Findings include: Review of CAP proficiency records revealed a score of 40% for CK in the 3rd event of 2017. During an interview on 02/13 /2019 at 3:30 PM, the TS confirmed the failed proficiency testing score. 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 -- D2109 TOXICOLOGY CFR(s): 493.845(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review of College of American Pathologist (CAP) proficiency testing records and interview with Technical Supervisor (TS), the laboratory failed to score at least 80 % for analyte Theophylline in 1 (1st event of 2017) out of 6 events for Toxicology reviewed. Findings include: Review of CAP proficiency records revealed a score of 60% for Theophylline in the 1st event of 2017. During an interview on 02 /13/2019 at 3:30 PM, the TS confirmed the proficiency testing score. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review of College of American Pathologist (CAP) proficiency testing records and interview with Technical Supervisor (TS), the laboratory failed to score at least 80 % on Blood Cell Identification (BCI) for 1 (3rd event of 2018) out of 6 events for Hematology reviewed. Findings include: Review of CAP proficiency records revealed a score of 60% for BCI in the 3rd event of 2018. During an interview on 02 /13/2019 at 3:30 PM, the TS confirmed the failed proficiency testing score. D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review of College American Pathologist (CAP) proficiency testing records and interview with Technical Supervisor (TS), the laboratory received an unsatisfactory score in 1 (3rd event of 2017) out of 6 events for Hematology reviewed. Findings include: Review of CAP proficiency records for 2017 and 2018 revealed that the laboratory received a 0 % score for Hematocrit and Hemoglobin resulting in an overall score of 75 %. During an interview on 02/13/2019 at 3:30 PM, the TS confirmed that the laboratory failed the event of reference. -- 2 of 2 --