Medlogic, Llc

Summary Statement of Deficiencies D0000 A Complaint Survey was performed at Medlogic, LLC- CLIA ID 19D2066157 on July 29, 2020 through July 29, 2020. Medlogic, LLC was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.801 CONDITION: Enrollment and testing of samples 42 CFR 493.1441 CONDITION: Laboratories performing high complexity testing; Laboratory Director 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 observation, record review, and interview with personnel, the laboratory failed to ensure proficiency testing samples were not referred to another laboratory for testing. Refer to D2013. D2013 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(4) The laboratory must not send proficiency testing samples or portions of proficiency testing samples to another laboratory for any analysis for which it is certified to perform in its own laboratory. Any laboratory that CMS determines intentionally referred a proficiency testing sample to another laboratory for analysis may have its 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 -- certification revoked for at least one year. If CMS determines that a proficiency testing sample was referred to another laboratory for analysis, but the requested testing was limited to reflex, distributive, or confirmatory testing that, if the sample were a patient specimen, would have been in full conformance with written, legally accurate and adequate standard operating procedures for the laboratory's testing of patient specimens, and if the proficiency testing referral is not a repeat proficiency testing referral, CMS will consider the referral to be improper and subject to alternative sanctions in accordance with 493.1804(c), but not intentional. Any laboratory that receives a proficiency testing sample from another laboratory for testing must notify CMS of the receipt of that sample regardless of whether the referral was made for reflex or confirmatory testing, or any other reason. This STANDARD is not met as evidenced by: Based on direct observation by surveyors, review of the laboratory's proficiency testing (PT) records and CLIA 116 application, as well as interview with the Technical Supervisor and manager, the laboratory failed to ensure 2019 and 2020 College of American Pathologists (CAP) proficiency samples for respiratory and COVID testing issued to the laboratory (19D2066157) were not referred to another CLIA laboratory (19D2185370) for testing. Findings: 1. In interview on July 27, 2020 at 10:16 am, Technical Supervisor 1 of their sister laboratory (19D2185370 - Molecular) stated prior to June 3, 2020 the Respiratory Panel and COVID testing were performed under this laboratory's CLIA Identification number, 19D2066157. 2. Review of the laboratory's (19D2066157) CLIA 116 Application revealed the laboratory is enrolled in Chemistry and Hematology specialties, not in Bacteriology and Virology. 3. Interview with the Technical Supervisor on July 29, 2020 at 9:30am revealed the laboratory (19D2066157) ceased testing in February 2020. 4. Review of the CLIA 116 Initial Application for the sister-molecular laboratory 19D2185370 revealed the Louisiana State Agency received their CLIA application June 1, 2020. The specialties for testing indicated on the application were Bacteriology and Virology. 5. Review of the Disclosure of Ownership and CLIA 116 applications for this laboratory 19D2066157 and the sister-molecular laboratory 19D2185370 revealed the laboratories share the same owner but different Laboratory Directors. 6. Review of the laboratory's (19D2066157) PT documents revealed the following three (3) PT events referred to the sister molecular laboratory (19D2185370): IDR-B 2019 Infectious Disease, Respiratory; Method: Lab-Developed Test; Original Evaluation: 08 /16/2019 IDR-C 2019 Infectious Disease, Respiratory; Method: Lab-Developed Test; Original Evaluation: 1/10/2020 COV2-A 2020; SARS-CoV-2, Molecular 2020; Original Evaluation: 07/02/2020 7. In interview on July 27, 2020 at 11:00 am, Testing Personnel 1 from the sister-molecular laboratory (19D2185370) stated he did not keep instrument printouts, but that he manually wrote patient results prior to June 2020 for Respiratory Panel testing. 8. Further review of the 2019 PT documents for laboratory 19D21066157 revealed Technical Supervisor 1 of the sister-molecular laboratory (19D2185370) signed the CAP evaluation forms for both events on May 26, 2020. 9. Further review of the CAP PT 2019 & 2020 evaluation forms revealed the laboratory performed PT testing on five (5) samples of each for the following viruses and bacteria: Influenza A virus, Influenza B virus, Parainfluenza, RSV, Rhinovirus /Enterovirus, Metapneumovirus, Adenovirus, Chlamydophila pneumonia, Mycoplasma pneumonia, Legionella pneumophila, Bordetella pertussis, Bocavirus, Parainfluenza virus IV, and Coronavirus. 10. Review of proficiency test records for Respiratory and COVID testing revealed the laboratory did not include the following: a) 2019 IDR-B Infectious Disease, Respiratory: signed attestation statement and raw instrument data b) 2019 IDR-C Infectious Disease, Respiratory: signed attestation -- 2 of 3 -- statement and raw instrument data c) 2020 COV2-A: signed attestation statement 11. Review of CAP records for COV2-A 2020 revealed the PT event was issued to 19D2066157 on May 18, 2020. Raw data reviewed confirmed the samples were tested on June 10, 2020 by Testing Personnel 1 of the sister laboratory (19D2185370). The event was signed by the laboratory director of the sister laboratory (19D2185370) on July 29, 2020. The testing performed by the sister laboratory (19D2185370) was evaluated by CAP and copied to CMS under 19D2066157 on July 2, 2020. 12. In interview on July 27, 2020 at 10:05 am the Quality Assurance personnel for the sister laboratory (19D2185370) stated the sister laboratory began COVID testing on May 15, 2020. In interview on July 27, 2020 at 10:09 am Technical Supervisor 1 of the sister laboratory (19D2185370) stated the sister laboratory began respiratory testing on April 26 or 28, 2020. In interview on July 27, 2020 at 11:05 am, Testing Personnel from sister laboratory (19D2185370) stated the sister laboratory began respiratory testing in March 2020. 13. Defined date when patient testing or proficiency testing moved from the original laboratory to the sister laboratory is undetermined. 14. Direct observation by surveyors on July 27, 2020 at 11:27 am, revealed the sister laboratory (19D2185370) had the 2020 second event "IDR-B 2020 Infectious Disease, Respiratory Panel" CAP PT paperwork in the laboratory testing area. Review of the 2020 second event PT records for Respiratory Panel revealed the CLIA ID number indicated on the PT paperwork was 19D2066157, not the sister molecular laboratory (19D2185370). 15. In interview on July 27, 2020 at 11:27 am, Testing Personnel from the sister laboratory (19D2185370) stated the laboratory performed a CAP PT testing event for respiratory in December 2019. 16. In interview on July 29, 2020 at 10:28 am, the Manager of the sister laboratory (19D2185370) stated for 2020 the first PT event was missed for respiratory tested. The Manager further stated he ordered respiratory and COVID PT events from CAP on May 15, 2020. 17. In interview on July 29, 2020 at 3:44 pm, the Manager of the sister laboratory (19D2185370) stated he had contacted CAP about the CLIA ID number within the last 3 weeks. He further stated he thought the CLIA ID number on the 2020 second event was corrected to 19D2185370 and was unsure of why it had not been changed. 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 observation, record review, and interview with personnel, the Laboratory Director failed to provide overall management and direction. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on observation, record review and interview with personnel, the Laboratory Director failed to ensure proficiency samples are tested as required. Refer to D2013. -- 3 of 3 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: A Revisit survey was performed at Medlogic, LLC-CLIA ID # 19D2066157 on June 19, 2019 through June 21, 2019. Based on review of the laboratory's Allegation of Compliance and

Summary Statement of Deficiencies D0000 A Complaint Survey # LA00049879 was performed at Medlogic, LLC-CLIA ID # 19D2066157 on October 30 , 2018 through November 1, 2018. Medlogic, LLC was found not in compliance with the following CONDITION LEVEL DEFICIENCIES which constitute an IMMEDIATE JEOPARDY to the patients serviced by the laboratory: 42 CFR 493.1240 CONDITION: Preanalytic Systems 42 CFR 493.1250 CONDITION: Analytic Systems 42 CFR 493.1290 CONDITION: Postanalytic Systems 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing, Laboratory Director 42 CFR 493.1409 CONDITION: Laboratories performing moderate complexity testing, Technical Consultant 42 CFR 493.1771 CONDITION: Inspection Requirements 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 observation, record review, and interview with personnel, the laboratory failed to have a system in place to retain test records. Findings: 1. Observation by surveyors during survey October 30, 2018 through November 1, 2018 revealed the laboratory was unable to provide requested instrument printouts. 2. In interview on October 31, 2018 at 11:47 am, Personnel 4 stated she was unable to locate the requested instrument printouts. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 30 -- 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 with personnel, the laboratory's system failed to monitor, assess, and correct problems identified with the preanalytic system. Findings: 1. The laboratory failed to obtain a written request from the physician for Chemistry testing for three (3) of ten (10) patients reviewed. Refer to D5301. 2. The laboratory failed to ensure test requisitions included all tests performed at the laboratory. Refer to D5305 I. 3. The laboratory failed to ensure test requisitions included the collection date. Refer to D5305 II. 4. The laboratory failed to ensure patient blood samples for Chemistry and Hematology testing are stored and preserved per manufacturer requirements. Refer to D5311. 5. The laboratory failed to document the date and/or time specimens are received into the laboratory. Refer to 5313. 6. The laboratory failed to establish complete detailed written instructions for providers to maintain the integrity of samples and ensure accurate and reliable testing. Refer to D5317. 7. The laboratory failed to establish procedures to monitor, assess, and correct problems, identified with the preanalytic system. Refer to D5391. 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 with personnel, the laboratory failed to obtain a written request from the physician for Chemistry testing for three (3) of ten (10) patients reviewed. Findings: 1. Review of random selection of patient test requisitions and final test reports for September 2018 and October 2018 revealed the laboratory reported analytes that did not have a written request for the following three (3) patients: Patient 18: Test requisition: Tests selected: Hematology (Complete Blood counts (CBC): manual diff), CRP, and Metabolic panel (includes: BUN, Creatinine, eGFR, Sodium, Potassium, Anion Gap, Chloride, CO2, Calcium, Phosphorus, Magnesium, ALT, AST, ALP, Albumin, Total Bilirubin, Direct Bilirubin, Total Protein, Amylase, Lipase, Ferritin, Folate, Vitamin B12, Vitamin D, and Iron). Patient Final Test Report: Included results for analytes included in the Diabetes Prevention Panel (includes: Glucose, Hemoglobin A1C, Insulin, Growth Hormone, Cortisol, C- peptide), Cardiovascular Panel (includes: HDL, LDL, Cholesterol, Triglycerides, Lipoprotein, Apo A, Apo B) and Hormone Panel (includes: Testosterone, DHEA-S, SHBG, Cortisol, LH, FSH, Growth Hormone, Free T3, Prolactin, Beta hCG, Estradiol, Progesterone, TSH, Total T3, Total T4, and PSA). Patient 111: Test requisition: Tests selected: CBC, Manual Diff, Metabolic panel (includes: BUN, Creatinine, eGFR, Sodium, Potassium, Anion Gap, Chloride, CO2, Calcium, Phosphorus, Magnesium, ALT, AST, ALP, Albumin, Total Bilirubin, Direct Bilirubin, Total Protein, Amylase, Lipase, Ferritin, Folate, Vitamin B12, Vitamin D, and Iron), Diabetes Prevention Panel (includes: Glucose, Hemoglobin A1C, Insulin, Growth Hormone, Cortisol, C-peptide), and Hormone Panel (includes: Testosterone, -- 2 of 30 -- DHEA-S, SHBG, Cortisol, LH, FSH, Growth Hormone, Free T3, Prolactin, Beta hCG, Estradiol, Progesterone, TSH, Total T3, Total T4, and PSA). Patient Final Test Report: Included results for Cardiovascular Panel (includes: HDL, LDL, Cholesterol, Triglycerides, Lipoprotein, Apo A, Apo B) , Homocysteine, and automated differential for CBC. The laboratory did not have documentation that a manual differential for CBC was performed. Patient 116: Reported GGT and N-MID Osteocalcin without test request 2. In interview on October 30, 2018 at 11:50 am, Personnel 3 stated physicians order specific tests. Personnel 3 further stated all samples are not tested for all analytes, Wellness Panel, unless ordered. Wellness Panel includes: Hematology Panel, Inflammation (CRP and Homocysteine), Metabolic Panel, Diabetes Prevention Panel, Cardiovascular Panel, and Hormone Panel. 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: I. Based on record review and interview with personnel, the laboratory failed to ensure test requisitions included all tests performed at the laboratory. Findings: 1. Review of the laboratory's test requisitions revealed the following tests were not included: GGT,TIBC, Transferrin. 2. In interview on October 31, 2018 at 1:07 pm, Personnel 2 stated the laboratory performs GGT and TIBC testing. Personnel 2 further stated the laboratory's requisition forms need to be updated to include GGT and TIBC. II. Based on record review and interview with personnel, the laboratory failed to ensure test requistions included the collection date. Findings: 1. Review of random selection of patient test requisitions revealed the collection date was not included for the following two (2) patients: Patient 17 Patient 110 2. In interview on October 31, 2018, Personnel 4 stated the collection date should be documented on all requisitions. 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. -- 3 of 30 -- This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to ensure patient blood samples for Chemistry and Hematology testing are stored and preserved per manufacturer requirements. Findings: 1. Observation by surveyor on October 31, 2018 at 10:33 am revealed the laboratory receives blood samples via United Parcel Service (UPS) in a styrofoam cooler with ice packs. Further observation revealed laboratory personnel taking the temperature of the styrofoam container once opened; however, this temperature was not documented. 2. Review of the Chemistry and Hematology package inserts revealed the following: a) Beckman Coulter Access 2 for testing of Insulin, Growth Hormone, Cortisol, Testosterone, DHEA-sulfate, SHBG, Luteinizing Hormone, FSH, Free T3, Prolactin, Beta-hCG, Estradiol, Progesterone, TSH, Total T3, Total T4, PSA, Ferritin, Folate, Vitamin B12, Vitamin D: "If the assay will not be completed within 48 hours, or for shipment of samples, freeze at -20 degrees Celsius or colder." b) AU 480: b1) Creatinine: serum stable for 24 hours at refrigerated temperature and several months when frozen at -20 degrees Celsius. b2) Direct Bilirubin: should be analyzed within two (2) hours of collection if kept at room temperature in the dark and within twelve (12) hours if kept refrigerated (2-8 degrees Celsius) and protected from light. Bilirubin in serum is stable for three (3) months frozen ( -20 degrees Celsius) and protected from light. b3) Total Bilirubin: should be analyzed within two (2) hours of collection if kept at room temperature in the dark and within twelve (12) hours if kept refrigerated (2-8 degrees Celsius) and protected from light. Bilirubin in serum is stable for three (3) months frozen (-20 degrees Celsius) and protected from light. b4) Magnesium: use fresh , unhemolyzed serum or heparinzed plasma b5) Lipoprotein (a): after sampling, the test should be performed without delay. If the test cannot be done immediately, the sample should be placed in a tightly sealable container and stored at -20 degrees Celsius or below. b6) Homocysteine: place all specimens (serum and plasma on ice after collection and prior to processing. All specimens may be kept on ice for up to 6 hours prior to separation by centrifugation. Separate red blood cells from serum of plasma by centrifugation and transfer to a sample cup or other clean container. Specimens not placed on ice immediately may exhibit a 10-20 % increase in homocysteine concentration. If the assay will be performed within 2 weeks after collected, the specimen should be stored at 2-8 degrees Celsius. If the testing will be delayed more than 2 weeks, should be stored frozen at -20 degrees Celsius or colder. c)Medonic M- series (CBC): "Stable at room temperature for 48 hours." 4. The laboratory did not provide surveyors with reagent inserts for the following analytes: Sodium, Potassium, Chloride 5. Further observation by surveyor on October 31, 2018 at 10:51 am revealed Personnel 3 received the following seven (7) samples: Patients 39-45 (collection dates: 10/30/18; tests ordered Complete Wellness Panel includes CBC). Surveyor observed Personnel 3 place the identified seven (7) samples in the refrigerator after accessioning was complete. 6. In interview on October 31, 2018 at 10:38 am, Personnel 3 stated all specimens should be received at 2-8 degrees Celsius, no other handling requirements were used for specimen acceptability. Personnel 3 further stated the laboratory does not document the temperature of samples upon receipt. 7. Observation by surveyor on November 1, 2018 at 11:40 am revealed the identified seven (7) samples in the refrigerator, exceeding the stated manufacturer stated sample handling requirements. 9. Review of the laboratory's Task 1 and 3 forms revealed the laboratory did not include the annual volumes for each. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) -- 4 of 30 -- 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 with personnel, the laboratory failed to document the date and/or time specimens are received into the laboratory. Findings: 1. Observation by surveyor on October 31, 2018 at 10:33 am, revealed shipments of blood samples are received in the laboratory via United Parcel Service (UPS) from outside providers. 2. Review of random patient test requisitions from September 2018 to October 2018 revealed the laboratory did not have documentation of the date and/or time of specimen receipt for the following patients: Patient 11 Patient 13 Patients 17-21 Patients 33 Patient 39 Patient 120 Patient 122 3. Review of the laboratory's policy and procedure manual revealed the laboratory did not have a written policy for receipt of specimens. 4. In interview on October 31, 2018 at 10:33 am, Personnel 3 stated the laboratory labels requisitions with the date of sample receipt. Personnel 3 confirmed the laboratory does not document the time of sample receipt. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to establish complete detailed written instructions for providers to maintain the integrity of samples and ensure accurate and reliable testing. Findings: 1. Observation by surveyors during laboratory tour on October 30, 2018 revealed the laboratory utilizes the following instruments for Chemistry and Hematology testing: a) AU 480: Albumin (Alb), Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT), Amylase, Apolipoprotein A1 (APO A1), Apolipoprotein B (APO B), Aspartate Aminotransferase (AST), Direct Bilirubin (DBil), Total Bilirubin (TBil), Calcium (CA), Chloride (CL), Carbon Dioxide (CO2), Creatinine (Creat), Cholesterol, Gamma- Glutamyl Transferase (GGT), Iron. High Density Lipoprotein Cholesterol (HDL), Low Density Lipoprotein Cholesterol (LDL), Lipoprotein, Lipase, Magnesium, C Reactive Protein (CRP), Glucose (Glu), Hemoglobin A1C (HgbA1C), Phosphorus, Potassium (K), Sodium (NA), Total Protein (TP), Blood Urea Nitrogen (BUN), Triglyceride (Trig). b) Access 2: Insulin, Growth Hormone, Cortisol, Testosterone, DHEA-sulfate, SHBG, Luteinizing Hormone, FSH, Free T3, Prolactin, Beta-hCG, Estradiol, Progesterone, TSH, Total T3, Total T4, PSA, Ferritin, Folate, Vitamin B12, Vitamin D. c) Medonic M Series: Complete Blood Counts (CBC) 2. Review of the "Specimen Collection and Preparation" document revealed the following information was not included for each instrument used for Chemistry and Hematology patient testing: (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. 3. In interview on October 30, 2018, Personnel 3 stated the laboratory provides clients the "Specimen Collection and Preparation" document. -- 5 of 30 -- D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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: Based on observation, record review, and interview with personnel, the laboratory failed to establish procedures to monitor, assess, and correct problems, identified with the preanalytic system. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory failed to have a Quality Assurance Policy to identify any of the deficiencies identified with the preanalytic system. 2. The laboratory failed to obtain a written request from the physician for Chemistry testing for three (3) of ten (10) patients reviewed. Refer to D5301. 3. The laboratory failed to ensure test requisitions included all tests performed at the laboratory. Refer to D5305 I. 4. The laboratory failed to ensure test requisitions included the collection date. Refer to D5305 II. 5. The laboratory failed to ensure patient blood samples for Chemistry and Hematology testing are stored and preserved per manufacturer requirements. Refer to D5311. 6. The laboratory failed to document the date and/or time specimens are received into the laboratory. Refer to 5313. 7. The laboratory failed to establish complete detailed written instructions for providers to maintain the integrity of samples and ensure accurate and reliable testing. Refer to D5317. 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: Based on observation, record review, and interview with personnel, the laboratory failed to ensure the quality of testing within the analytic systems. Findings: 1. The laboratory failed to establish a complete policy and procedure manual. Refer to D5401. 2. The laboratory failed to ensure the procedure manual contained complete policies and procedures. Refer to D5403. 3. The laboratory failed to address flags appearing on Complete Blood Counts (CBC) per manufacturer requirements. Refer to D5411 I. 4. The laboratory failed to address flags appearing on Chemistry results per manufacturer requirements. Refer to D5411 II. 5. The laboratory failed to address flags appearing on Endocrinology results per manufacturer requirements. Refer to D5411 III. 6. The laboratory failed to ensure patient samples for Chemistry were tested per manufacturer's requirements. Refer to D5411 IV. 7. The laboratory failed to ensure patient samples for Hematology were tested per manufacturer's requirements. Refer to D5411 V. 8. the laboratory failed to mix Hematology controls per manufacturer requirements. Refer to D5411 VI. 9. The laboratory failed to ensure supplies have not exceeded their expiration date. Refer to D5417. 10. The laboratory failed to have complete performance verification studies for Chemistry testing. Refer -- 6 of 30 -- to D5421 I. 11. The laboratory failed to have complete performance verification studies for Hematology testing. Refer to D5421 II. 12. The laboratory failed to establish calibration procedures for Hematology testing. Refer to D5425 I. 13. The laboratory failed to establish calibration procedures for Sodium, Potassium, and Chloride testing. Refer to D5425 II. 14. The laboratory failed to establish quality control procedures that monitor accuracy and precision for Chemistry testing to detect immediate errors. Refer to D5441. 15. the laboratory failed to establish their own mean and ranges for Quality Control (QC) material utilized for Chemistry testing as required by manufacturer. Refer to D5469. 16. The laboratory failed to perform

Summary Statement of Deficiencies D0000 An Initial Certification Survey was conducted on April 30, 2018 at Medlogic, LLC - CLIA ID # 19D2066157. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to ensure that proficient testing (PT) documents were signed appropriate personnwl. Findings: 1. Review of the laboratory's PT records for 2017 and 2018 revealed the attestation statements were signed by the testing personnel only. The laboratory director did not sign all PT documents. 2. In interview on April 30, 2018, Personnel 2 stated the laboratory director was not on site to sign all documents but comes quarterly and reviews all proficiency testing documents. Personnel 2 confirmed that testing personnel also listed as general supervisor had signed PT documents. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) 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 -- The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require