Southern Diagnostics Laboratory

Summary Statement of Deficiencies D0000 A Complaint Survey was performed at Medlogic, LLC- CLIA ID 19D2185370 on July 27, 2020 through July 29, 2020. 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 493.1441 CONDITION: Laboratories performing high complexity testing, Laboratory Director A Complaint Survey was performed at Medlogic, LLC- CLIA ID 19D2185370 on July 27, 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 493.1250 CONDITION: Analytic Systems 42 CFR 493.1459 CONDITION: Laboratories performing high complexity testing; General Supervisor 42 CFR 493.1487 CONDITION: Laboratories performing high complexity testing; Testing Personnel 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 testing and reporting of proficiency samples of another CLIA laboratory did not occur. Findings: 1.The laboratory failed to ensure no inter- 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 -- laboratory communications occurred for proficiency testing samples prior to the cut- off date for submission of test results for four (4) of four (4) testing events reviewed. Refer to D2011. 2. The laboratory failed to report to Centers for Medicaid and Medicare Services (CMS) the receipt of proficiency testing samples from another laboratory. Refer to D2013. D2011 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(3) Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample (s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. Laboratories with multiple testing sites or separate locations must not participate in any communications or discussions across sites/locations concerning proficiency testing sample results until after the date by which the laboratory must report proficiency testing results to the program. This STANDARD is not met as evidenced by: Based on observation, proficiency testing record review, and interview with personnel, the laboratory failed to ensure no inter-laboratory communications occured for proficiency testing samples prior to the cut-off date for submission of test results for four (4) of four (4) testing events reviewed. Findings: 1. Observation by surveyors during the laboratory tour on July 27, 2020 at 10:21 am revealed the laboratory utilizes two (2) Quant Studio 12K Flex instruments for the following high complexity testing: Respiratory Panel (includes Bordetella pertussis, Bordetella pan., Chlamydophila pneumoniae. Haemophilus influenza, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pnuemoniae, Streptococcus pneumoniae, Streptococcus pyogenes (Group A), Klebsiella pneumylococcus aureus, Adenovirus (Type 1 & 2), Bocavirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus (HMPV) A, HMPV B, Enterovirus (Pan, D68), Rhinovirus (Type 1 &2), Influenza A (Pan, H1, H3), Influenza B (Pan), Parainfluenza virus (PIV) 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, RSV A, and RSV B) and SARS COV-2. 2. Review of the laboratory's 2019 and 2020 College of American Pathologists (CAP) proficiency testing records for 2019 and 2020 revealed the laboratory recieved, tested, and reported results for proficiency testing (PT) samples that were issued to their sister laboratory ( 19D2066157). Refer to D2013. 3. In interview on July 29, 2020 at 3:44 pm, the Manager of the sister laboratory (19D2066157) 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 correct and was unsure of why it had not been changed. 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 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 -- 2 of 30 -- 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 observation, record review, and interview with personnel, the laboratory failed to report to Centers for Medicaid and Medicare Services (CMS) the receipt of proficiency testing samples from another laboratory. Findings: 1. Observation by surveyors during the laboratory tour on July 27, 2020 at 10:21 am revealed the laboratory utilizes two (2) Quant Studio 12K Flex instruments for the following high complexity testing: Respiratory Panel (includes Bordetella pertussis, Bordetella pan., Chlamydophila pneumoniae. Haemophilus influenza, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pnuemoniae, Streptococcus pneumoniae, Streptococcus pyogenes (Group A), Klebsiella pneumylococcus aureus, Adenovirus (Type 1 & 2), Bocavirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus (HMPV) A, HMPV B, Enterovirus (Pan, D68), Rhinovirus (Type 1 &2), Influenza A (Pan, H1, H3), Influenza B (Pan), Parainfluenza virus (PIV) 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, RSV A, and RSV B) and SARS COV-2. 2. In interview on July 27, 2020 at 10:16 am, Technical Supervisor 1 stated prior to June 3, 2020 the Respiratory Panel and COVID testing were performed under their sister laboratory's CLIA Identification number (19D2066157). 3. In interview on July 27, 2020 at 11:27 am, Testing Personnel 1 stated the laboratory (19D2185370) tested PT samples in December 2019 and had an event that was recently received that had not been tested yet. 4. Surveyors observed on July 27, 2020 at 11:27 am, the laboratory had the 2020 second event "IDR-B 2020 Infectious Disease, Respiratory Panel" College of American Pathologists (CAP) proficiency testing (PT) paperwork on the desk in the molecular laboratory. 5. Review of the 2020 second event records for Respiratory Panel revealed the CLIA ID number indicated on the paper work was that of the sister laboratory (19D2066157), not the molecular laboratory (19D2185370). 6. Review of the laboratory's PT records revealed the following: a) No documentation of participation in the 2020 first PT event for Respiratory Panel b) Documentation of 2019 second and third PT events ( IDR-B and IDR-C) for Respiratory Panel performed by the laboratory c) No signed attestation for COV2-A 2020 d) No documentation of communication with CMS regarding the receipt of PT samples from another laboratory 7. Further Review of CAP records for COV2-A 2020 revealed the PT event was issued to the sister laboratory 19D2066157. Raw data reviewed confirmed the samples were tested instrument #285881360 on June 10, 2020 by Testing Personnel 1. The event was signed by the laboratory director on July 29, 2020. The testing performed by the laboratory was evaluated by CAP and copied to CMS under 19D2066157 on July 2, 2020. 8. Further review of the laboratory's 2019- 2020 PT records for Respiratory Panel revealed the CLIA ID number of the sister laboratory (19D2066157) was listed. Technical Supervisor 1 signed the evaluations on "5-26-2020." 9. In interview on July 29, 2020 at 3:44 pm, the Manager of the sister laboratory (19D2066157) 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 -- 3 of 30 -- second event was correct and was unsure of why it had not been changed. D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to retain a copy of discontinued test procedure for antibiotic resistance testing. Findings: 1. Review on July 29, 2020 of random selection of patient final reports from July 2020 revealed the laboratory performed antibiotic resistance marker testing. 2. Review of the laboratory's policy and procedure manual and test menu revealed the laboratory did not include antibiotic resistance testing records. The initial date of testing and discontinuance were not documented. 3. In interview on July 28, 2020, Testing Personnel 1 stated the laboratory previously performed antibiotic resistance testing. Testing Personnel 1 stated the validation studies were performed on the laboratory's previous analyzer Quant Studio 3, not the current instruments Quant Studio 12 K Flex (installed in March 2020). 4. In interview on July 29, 2020 at 10:32 am, Technical Supervisor 1 stated the laboratory discontinued antibiotic resistance testing on July 8, 2020. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to have a system for handling complaints and problems reported to the laboratory. Findings: 1. Review of the laboratory's policy and procedure manual on July 27, 2020 revealed the laboratory did not have a written policy and procedure for addressing internal complaints and problems reported to the laboratory. 2. In interview on July 27, 2020 at 1:53 pm, the Quality Assurance Manager stated the laboratory did not have a policy /procedure for complaints. 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: I. Based on record review and interview with personnel, the laboratory failed to establish written policies and procedures to assess competency for testing personnel. -- 4 of 30 -- Findings: 1. Review of the laboratory's policy and procedure manual on July 27, 2020 revealed the laboratory did not include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel performing laboratory testing, as well as frequency of performance: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills. 2. In interview on July 27, 2020 at 12:47 pm, the Quality Assurance Manager stated the laboratory did not have a policy for competency assessment. II. Based on record review and interview with personnel, the laboratory failed to establish written policies and procedures to address competency for two (2) of two (2) Technical Supervisors and General Supervisors reviewed were complete. Findings: 1. Review of the laboratory's CMS 209 form on July 27, 2020 (Laboratory Personnel Report revealed the following two (2) personnel serve and/or previously served as Technical Supervisor and General Supervisor: Technical Supervisor and General Supervisor 1 (current position) Technical Supervisor and General Supervisor 2 (previously employed) 2. In interview on July 27, 2020, the Quality Assurance (QA) Manager stated Technical Supervisor/General Supervisor 2 is no longer employed at the laboratory. The QA personnel further stated she left the position approximately two weeks prior. 3. Review of the laboratory's policy and procedure manual revealed the laboratory did not include competency assessment criteria or frequency of performance for personal serving as Technical Supervisor and General Supervisor. 4. Review of personnel records on July 27, 2020 revealed the laboratory did not have documentation of competency assessments for Technical Supervisor/General Supervisor 1 and Technical Supervisor/General Supervisor 2. 5. In interview on July 27, 2020 at 12:47 pm, the Quality Assurance Manager stated the Laboratory Director did not perform a competency assessment for the duties of Technical Supervisor /General Supervisor 1. QA Personnel further stated the Laboratory Director did not perform an assessment for technical and general supervisory duties for Technical Supervisor/General Supervisor 2. 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 observation, record review, and interview with personnel, the laboratory failed to ensure the accuracy of non regulated Bacteriology and Virology analytes at least twice annually. Findings: 1. Observation by surveyors during the laboratory tour on July 27, 2020 at 10:21 am revealed the laboratory utilizes two (2) Quant Studio 12K Flex instruments for the following high complexity testing: Respiratory Panel (includes Bordetella pertussis, Bordetella pan., Chlamydophila pneumoniae. Haemophilus influenza, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Streptococcus pneumoniae, Streptococcus pyogenes (Group A), Klebsiella pneumylococcus aureus, Adenovirus (Type 1 & 2), Bocavirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human -- 5 of 30 -- Metapneumovirus (HMPV) A, HMPV B, Enterovirus (Pan, D68), Rhinovirus (Type 1 &2), Influenza A (Pan, H1, H3), Influenza B (Pan), Parainfluenza virus (PIV) 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, RSV A, and RSV B) and SARS COV-2. 2. Review of the laboratory's policy and procedure manual revealed the laboratory did not include a written policy for twice a year verification of all non regulated analytes to ensure the accuracy of testing. 3. In interview on July 27, 2020 at 2:03 pm, the Quality Assurance Manager stated the laboratory did not have a policy for twice a year verification to ensure accuracy of Bacteriology and Virology testing. 4. In interview on July 27, 2020 at 3:31 pm, Technical Supervisor 1 stated the laboratory is enrolled in College of American Pathologists (CAP) proficiency testing (PT) to ensure the accuracy of testing. 5. In interview on July 29, 2020 at 2:38 pm, the Quality Assurance Manager stated CAP does not cover all the analytes the laboratory tests for. 6. Review of the untitled list, with column "Covered by CAP," provided to surveyor on July 29, 2020 revealed the following bacteria and viruses are not included in the CAP survey: a) "Haemophilus influenza b) Moraxella Catarrhalis c) Strep pneumoniae d) Strep pyogenes (Group A) e) Klebsiella pneumoniae f) Staph aureus g) Coronavirus 229 E; note included "X* CAP does not distinguish subtype" h) Coronavirus HKU1; note included "X* CAP does not distinguish subtype" i) Coronavirus NL63; note included "X* CAP does not distinguish subtype" j) Coronavirus OC43; note included "X* CAP does not distinguish subtype" k) HMPV A; note included "X* CAP does not distinguish subtype" l) HMPV B; note included "X* CAP does not distinguish subtype" m) PIV 1; note included "X* CAP does not distinguish subtype" n) PIV 2; note included "X* CAP does not distinguish subtype" o) PIV 3; note included "X* CAP does not distinguish subtype" 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 with personnel, the laboratory's system failed to meet the requirements of the preanalytical system. Findings: 1. The laboratory failed to establish specimen handling, stability, and acceptability/rejection requirements for Bacteriology and Virology testing. Refer to D5311 I. 2. The laboratory failed to ensure ten (10) of ten (10) random Respiratory and COVID samples from June 2020 to July 2020 were extracted per laboratory policy. Refer to D5311 II. 3. The laboratory failed to establish detailed written instructions for providers to maintain integrity of samples. Refer to D5317. 4 The laboratory failed to establish procedures to monitor, assess, and correct problems, identified with the preanalytic system. Refer to D5391. 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) -- 6 of 30 -- 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: I. Based on observation, record review and interview with personnel, the laboratory failed to establish specimen handling, stability, and acceptability/rejection requirements for Bacteriology and Virology testing. Findings: 1. Observation by surveyors during laboratory tour on July 27, 2020 at 10:21 am revealed the laboratory utilizes two (2) Quant Studio 12K Flex instruments for the following lab developed high complexity testing: Respiratory Panel (includes Bordetella pertussis, Bordetella pan., Chlamydophila pneumoniae. Haemophilus influenza, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pnuemoniae, Streptococcus pneumoniae, Streptococcus pyogenes (Group A), Klebsiella pneumylococcus aureus, Adenovirus (Type 1 & 2), Bocavirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus (HMPV) A, HMPV B, Enterovirus (Pan, D68), Rhinovirus (Type 1 &2), Influenza A (Pan, H1, H3), Influenza B (Pan), Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, RSV A, and RSV B) and SARS COV-2. 2. In interview on July 27, 2020 at 10:05 am the Quality Assurance personnel stated the laboratory began COVID testing on May 15, 2020. 3. In interview on July 27, 2020 at 10:09 am,Technical Supervisor 1 stated the laboratory began respiratory testing on April 26 or 28, 2020. 4.In interview on July 27, 2020 at 11:05 am, Testing Personnel 1 stated the laboratory began respiratory testing in March 2020. 5. Oberservation of laboratory's specimen receipt process on July 28, 2020 at 7:00am revealed the laboratory receives large shipments of patient samples in extra large styrofoam containers containing non-frozen ice packs at the bottom with patient samples filling on top. Further observation of this process revealed laboratory personnel did not detect or record specimen temperatures. Direct observation of surveyor at 7:35am on July 28, 2020 confirmed patient samples were not cool to touch. 6. In interview on July 28, 2020 at 7:30am, the manager of accessioning confirmed the temperature of samples is not checked by accessioning. 7. Observation by surveyor on July 28, 2020 at 8:56 am revealed accessioners separating samples based on test ordered. Surveyor observed the laboratory receiving samples in the following transport media tubes: a) Copan E-swab purple, white and green top tubes b) RMBIO 8. In interview on July 28, 2020 at 8:56 am, the manager of accessioning stated the different colored cap tubes depends on the manufacturer. 9. In interview on July 28, 2020 at 9:08 am the manager of accessioning stated she thought COVID samples are stable for a week and was unsure of the stability of respiratory panel samples. The manager of accessioning further stated the stability of the samples would be rejected on the laboratory side. The manager of accessioning further stated the accessioning area receives everything and rejects samples for missing demographic information, missing label or requisition; stability would be determined by the laboratory. 10. Review of the laboratory's records and policy and procedures revealed "Sample Collection, Handling and Shipping Condition" policy that revealed the following: a) Copan E swab transport media included b) Specimen handling stated "Place Oropharyngeal, Nasopharyngeal swabs or Nasopharyngeal wash/aspirate immediately into a sterile vial containing 1.0 ml of Liquid Amies transporting medium". c) Specimen storage conditions stated "after collection specimen samples can be either stored on ice packs or 4 degrees C until samples are received by Medlogic Laboratory." 11. Review of the e Swab package insert revealed "To maintain optimum organism viability, transport specimens collected using Eswab -- 7 of 30 -- directly to the laboratory, preferably within 2 hours of collection. If immediate delivery or processing is delayed, then specimens shoudl be refrigerated at 4-8 C or stored and room temperature (20-25 C) and processed within 48 hours except for Neisseria gonorrhoeae cultures, which should be processed within 24 hours." 12. Further review of the laboratory's "Sample Collection, Handling and Shipping Condition" revealed the following information was not included: a) the different types of transport media the laboratory utilizes/accepts, including RMBIO b) specimen collection instructions, including training documentation for staff employed by the laboratory b) specimen handling to include the acceptable sample type c) specific sample storage and transport requirements d) stability study including raw data e) specimen acceptability/ rejection requirements including but not limited to what demographic information is required 13. In interview on July 27, 2020 at 10:21 am, Technical Supervisor 1 stated the laboratory only accepts nasopharyngeal samples. 14. In interview on July 29, 2020 at 3:40 pm, the Quality Assurance Manager confirmed the laboratory did not perform sample stability studies. The Quality Assurance Manager further confirmed the laboratory did not establish specimen handling requirements. 15. In interview on July 29, 2020 at 12:20 pm, Technical Supervisor 1 stated since May 14, 2020 119,010 Respiratory Panel and 16,156 COVID tests have been analyzed. II. Based on observation, record review, and interview with personnel, the laboratory failed to ensure ten (10) of ten (10) random Respiratory and COVID samples from June 2020 to July 2020 were extracted per laboratory policy. Findings: 1. Oberservation of laboratory's specimen receipt process on July 28, 2020 at 7:00am revealed the laboratory receives large shipments of patient samples in extra large styrofoam containers. 2. Review of the laboratory's policy and procedure manual revealed "Specimen Receiving, Accessioning, and Rejection SOP" policy that stated "Note: If the specimen will be processed (nucleic acid (DNA/RNA) extraction) for analysis immediately keep it at room temperature (20 degrees Celsius-25 degrees Celsius) and if within 24 hours after collection, refrigerate at 4-8 degrees Celsius." 3. Review of the laboratory's records revealed the laboratory did not establish specimen stability. 4. In interview on July 27, 2020 at 10:21 am, Testing Personnel 1 stated molecular samples are extracted the same day they are received. 5. Review of random selection of respiratory and COVID patient final test reports from June 2020 to July 2020 revealed the following ten (10) patients were received/extracted after 24 hours of collection without documentation of refrigeration: Patient 2006150502: collected June 13, 2020; accessioned June 15, 2020 Patient 2006170530: collected June 13, 2020; accessioned June 17, 2020 Patient 2006200706: collected June 19, 2020; accessioned June 22, 2020 Patient 2006260646: collected June 24, 2020; accessioned June 26, 2020 Patient 2007011252: collected June 29, 2020; accessioned July 2, 2020 Patient 2007070578: collected July 2, 2020; accessioned July 7. 2020 Patient 2007100977: collected July 9, 2020 7:41; accessioned July 13, 2020 16:04 Patient 2007110975: collected July 10, 2020 8:30; accessioned July 14, 2020 10:15 Patient 2007160728: collected July 15, 2020 16:23; accessioned: July 17, 2020 15:08 Patient 2007280538: collected July 26, 2020; accessioned July 28, 2020 6. In interview on July 29, 2020 at 12:20 pm, Technical Supervisor 1 stated since May 14, 2020 119,010 Respiratory Panel and 16,156 COVID tests have been analyzed. 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. -- 8 of 30 -- This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to establish detailed written instructions for providers to maintain integrity of samples. Findings: 1. In interview on July 27, 2020 at 10:21 am, Technical Supervisor 1 stated the laboratory receives Respiratory Panel and COVID samples from all over the Gulf South. 2. Review of the laboratory's client list revealed the laboratory receives samples from Arizona, Alabama, Louisiana, Mississippi, Florida, Utah, Nevada, Tennessee, Georgia, Pennsylvania, and Texas. 3. Review of the laboratory's policy records revealed the laboratory did not establish a detailed written instructions for outside providers that includes the following: (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. 4. In interview on July 27, 2020 at 2: 34 pm, the Quality Assurance Manager stated the laboratory did not have a written client service manual for providers. 5. In interview on July 29, 2020 at 12:20 pm, Technical Supervisor 1 stated since May 14, 2020 119, 010 Respiratory Panel and 16,156 COVID tests have been analyzed. 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 establish specimen handling, stability, and acceptability/rejection requirements for Bacteriology and Virology testing. Refer to D5311 I. 3. The laboratory failed to ensure ten (10) of ten (10) random Respiratory and COVID samples from June 2020 to July 2020 were extracted per laboratory policy. Refer to D5311 II. 4. The laboratory failed to establish detailed written instructions for providers to maintain integrity of samples. Refer to D5317. 5. In interview on July 27, 2020 at 2:09 pm, the Quality Assurance Manager confirmed the laboratory did not have written quality assurance policies and procedures. 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. -- 9 of 30 -- 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 follow their established record retention policy. Refer to D5401 I. 2. The laboratory failed to establish a complete policy and procedure manual. Refer to D5401 II. 3. The laboratory failed to ensure the policy and procedure manual contained complete policies and procedures. Refer to D5403. 4. The laboratory failed to have current policies and procedures approved and signed by the current Laboratory Director. Refer to D5407. 5. The laboratory failed to establish performance specifications for Bacteriology and Virology testing on one (1) of two (2) Quant Studio 12 K Flex analyzers. Refer to D5423. 6. The laboratory failed to take