Sallie Astor Burdine Breast Foundation, The

Summary Statement of Deficiencies D0000 An INITIAL SURVEY was performed at THE SALLIE ASTOR BURDINE BREAST FOUNDATION - CLIA # 19D2135786 on July 23, 2018. THE SALLIE ASTOR BURDINE BREAST FOUNDATION 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 493.1230 CONDITION: General Laboratory Systems 42 CFR 493.1240 CONDITION: Preanalytic Systems 42 CFR 493.1250 CONDITION: Analytic Systems 42 CFR 493.1441 CONDITION: Laboratories performing high complexity testing, Laboratory Director 42 CFR 493.1447 CONDITION: Laboratories performing high complexity testing, Technical Supervisor 42 CFR 493.1459 CONDITION: Laboratories performing high complexity testing, General Supervisor 42 CFR 493.1487 CONDITION: Laboratories performing high complexity testing, Testing Personnel Test Systems identified as Research or Laboratory Developed Tests are considered high complexity testing and are subject to the CLIA regulations for Establishment and verification of performance specifications (42 CFR 493.1253(b)(2) and all other high complexity CLIA requirements. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, record review and interview with laboratory personnel, the laboratory failed to monitor and evaluate the overall quality of the General Laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 40 -- System. Findings: 1. The laboratory failed to establish policies and procedures that would ensure positive identification and optimum integrity of patient samples for "Lymphocyte Blastogenesis Assay" testing. Refer to D5203. 2. The laboratory failed to have a system in place to ensure that it documents all complaints and problems reported to the laboratory. Refer to D5205. 3. The laboratory failed to have a system in place to ensure that it identifies and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. Refer to D5207. 4. The laboratory failed to establish written policies to assess the competency of all employees. Please refer to D5209. 5. The laboratory failed to verify the accuracy of the performance of Lymphocyte Blastogenesis Assay at least twice annually. Refer to D5217. 6. The laboratory failed to establish written policies and procedures for monitoring, assessing, and correcting problems identified in the General Laboratory Systems. Please refer to D5291. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to establish policies and procedures that would ensure positive identification and optimum integrity of patient samples for "Lymphocyte Blastogenesis Assay" testing. Findings: 1. Review of Patient Final Reports revealed the laboratory performed and reported Lymphocyte Blastogenesis Assay" testing which included the following tumor markers: TAA, HTA, HTA HT-29, HTA SW480, HTA HTB-38, HTA NCI- 1640, HTA CRL 5833, HTA HTB58, CA 15-3, CA 125, CA 19-9, and CEA. 2. Review of the Laboratory Policy and Procedure Manual revealed the laboratory failed to establish written policies and procedures that ensures positive patient identification through specimen collection, labeling, accessioning, processing, (e.g., aliquoting), storage, testing, and reporting of results. Review the laboratory's system (policy and practices) for ensuring positive patient identification from specimen collection through reporting of results. 3. Interview with Personnel 2 on July 23, 2018 revealed he was unaware of all the policies and procedures that needed to be established. Personnel 2 confirmed the laboratory failed to establish written policies and procedure that would ensure positive identification and optimum integrity throughout the testing process. . 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 laboratory personnel the laboratory failed to have a system in place to ensure that it documents all complaints and problems -- 2 of 40 -- reported to the laboratory. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to have written policies and procedure for addressing complaints and problems reported to the laboratory. The policy should include a detailed procedure on how to address, document and handle complaints or problems reported to the laboratory. 2. Interview with personnel 2 on July 23, 2018 confirmed the laboratory failed to have a complete policy and procedure manual. D5207 COMMUNICATIONS CFR(s): 493.1234 The laboratory must have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel the laboratory failed to have a system in place to ensure that it identifies and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to have written policies and procedure to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. 2. Interview with personnel 2 on July 23, 2018 confirmed the laboratory failed to have a complete policy and procedure manual. 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 review of laboratory policy and procedure manual, and interview with personnel, the laboratory failed to establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to establish written policies and procedures that include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel involved in any phase of laboratory testing: 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. Interview with personnel 2 on July 23, 2018 confirmed the laboratory failed to have a complete policy and procedure manual. -- 3 of 40 -- 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 interview with personnel, the laboratory failed to verify the accuracy of the performance of Lymphocyte Blastogenesis Assay at least twice annually. Findings: 1. Review of Patient Final Reports revealed the laboratory performed and reported Lymphocyte Blastogenesis Assay" testing which included the following tumor markers: TAA, HTA, HTA HT-29, HTA SW480, HTA HTB-38, HTA NCI-1640, HTA CRL 5833, HTA HTB58, CA 15-3, CA 125, CA 19-9, and CEA. 2. Review of the laboratory's policy and procedure manual revealed the laboratory did not have a policy for twice a year verification of the accuracy of Lymphocyte Blastogenesis Assay . 3. Interview with Personnel 2 on July 23, 2018 revealed he was unaware the laboratory needed to verify the Lymphocyte Blastogenesis Assay twice a year. Personnel 2 confirmed the laboratory did not verify Lymphocyte Blastogenesis Assay twice a year. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on observation, record review and interview with laboratory failed to establish written policies and procedures for monitoring, assessing, and correcting problems identified in the General Laboratory Systems. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to establish policies and procedures for: a) The laboratory failed to establish policies and procedures that would ensure positive identification and optimum integrity of patient samples for "Lymphocyte Blastogenesis Assay" testing. Refer to D5203. b) The laboratory failed to have a system in place to ensure that it documents all complaints and problems reported to the laboratory. Refer to D5205. c) The laboratory failed to have a system in place to ensure that it identifies and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. Refer to D5207. d) The laboratory failed to establish written policies to assess the competency of all employees. Please refer to D5209. e) The laboratory failed to verify the accuracy of the performance of Lymphocyte Blastogenesis Assay at least twice annually. Refer to D5217. Further review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to establish written polices and procedure for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements . 2. Interview with personnel 2 on July 23, 2018 confirmed the laboratory failed to establish written policies and procedure for monitoring, assessing and correcting problems in General Laboratory Systems. -- 4 of 40 -- 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 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 seven (7) of nine (9) patients reviewed. Refer to D5301. 2. The laboratory failed maintain test requisitions that included all the required information for nine (9) of nine (9) patients. Refer to D5305. 3. The laboratory failed to establish complete written policies and procedures addressing specimen submission, handling, and referral. Refer to D5311 I. 4. The laboratory failed to ensure that a specimen stability study was performed to support their policy that samples for Lymphocyte Blastogenesis Assay must be processed within 48 hours of collection. Refer to D5311 II. 5. The laboratory failed to document the date and time specimens are received into the laboratory for nine (9) of nine (9) patients reviewed. Refer to D5313. 6. The laboratory failed to establish detailed written instructions for laboratory services provided for inpatient and outpatient testing and for maintaining the integrity of samples and ensuring accurate and reliable testing according to current manufacturers guidelines. Refer to D5317. 7. The laboratory's Quality Assurance (QA) system failed to monitor, assess, and correct problems identified with the Pre-analytic 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 seven (7) of nine (9) patients reviewed. Findings: 1. Review of a random selection of Patient Test Records for "Lymphocyte Blastogenesis Assay" testing (which includes tumor markers for: TAA, HTA, HTA HT-29, HTA SW480, HTA HTB-38, HTA NCI-1640, HTA CRL 5833, HTA HTB58, CA 15-3, CA 125, CA 19-9, and CEA) from July 5, 2017 through June 4, 2018 revealed the laboratory failed to obtain a written request from the physician for laboratory test orders of the following seven (7) patients: On June 4, 2018 Patient 1. On May 15, 2018 Patient 2. On April 19, 2018 Patient 3. On February 19, 2018 Patient 5. On January 18, 2018 Patient 6. On November 28, 2017 Patient 7. On September 6, 2017 Patient 8. 2. Interview with Personnel 2 on July 23, 2018 confirmed the laboratory failed to obtain written requests for Lymphocyte Blastogenesis Assay testing for the seven (7) patients cited above. -- 5 of 40 -- 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 with laboratory personnel, the laboratory failed maintain test requisitions that included all the required information for nine (9) of nine (9) patients. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory did not establish a written detailed test requisition policy and procedure that addresses the following required information:: a) 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. b) The patient's name or unique patient identifier. c) The sex and age or date of birth of the patient. d) The test(s) to be performed. e) The source of the specimen, when appropriate. f) The date and, if appropriate, time of specimen collection. g) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. h) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. 2. Interview with Personnel 2 on July 23, 2018 revealed he was unaware of the required information needed on a test requisition. 3. Review of a random selection of Patient Test Records for "Lymphocyte Blastogenesis Assay" testing (which includes tumor markers: TAA, HTA, HTA HT-29, HTA SW480, HTA HTB-38, HTA NCI-1640, HTA CRL 5833, HTA HTB58, CA 15-3, CA 125, CA 19-9, and CEA) from July 5, 2017 through June 4, 2018 revealed the laboratory failed to obtain a written request with the required information for laboratory test orders for the following nine (9) patients: On June 4, 2018 Patient 1. On May 15, 2018 Patient 2. On April 19, 2018 Patient 3. On March 15, 2018 Patient 4. On February 19, 2018 Patient 5. On January 18, 2018 Patient 6. On November 28, 2017 Patient 7. On September 6, 2017 Patient 8. On July 5, 2017 Patient 9. 2. Interview with Personnel 2 on July 23, 2018 confirmed the laboratory failed to obtain written requests containing all the required information for Lymphocyte Blastogenesis Assay testing for the nine (9) patients cited above. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of -- 6 of 40 -- 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: I. Based on record review and interview with personnel, the laboratory failed to establish complete written policies and procedures addressing specimen submission, handling, and referral. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to include written policies and procedures for "Lymphocyte Blastogenesis Assay" testing (which includes tumor markers: TAA, HTA, HTA HT-29, HTA SW480, HTA HTB-38, HTA NCI-1640, HTA CRL 5833, HTA HTB58, CA 15-3, CA 125, CA 19-9, and CEA) to include: a) Patient preparation. b) Specimen collection. c) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. d) Specimen storage and preservation. e) Conditions for specimen transportation. f) Specimen processing. g) Specimen acceptability and rejection. h) Specimen referral. 2. Interview with personnel 2 on July 23, 2018 revealed he was unaware of all the policies and procedures that were required. Personnel 2 confirmed the laboratory failed to have a complete policy and procedure manual. II. Based on observation record review and interview with personnel, the laboratory failed to ensure that a specimen stability study was performed to support their policy that samples for Lymphocyte Blastogenesis Assay must be processed within 48 hours of collection. Findings: 1. Observation by the surveyor during the tour of the laboratory on July 23, 2018 revealed the laboratory utilized the following equipment for processing and reading results for Lymphocyte Blastogenesis Assay: Beckman Coulter LS 6500 Liquid Scintillation Counter Skatron Basic 96 Harvester Two (2) Panasonic CO2 Incubators Nikon Microscope Olympus Microscope 2. Interview with Personnel 2 on July 23, 2018 revealed the laboratory had developed a test for "Lymphocyte Blastogenesis Assay" testing which includes tumor markers for: TAA, HTA, HTA HT-29, HTA SW480, HTA HTB-38, HTA NCI-1640, HTA CRL 5833, HTA HTB58, CA 15-3, CA 125, CA 19-9, and CEA. 3. Review of the Laboratory Policy and Procedure Manual revealed under specimen collection and preparation that samples are stored at room temperature for a maximum of 48 hours. Further review of the Policy and Procedure Manual revealed if a sample is not separated within 48 hours of drawing, then the assay is not set up. The ordering physician is sent a report stating "Lymphocytes not separated from blood within 48 hours of being drawn so assay was not set up. It will be necessary for you to redraw blood and submit for LBA." 4. Interview with Personnel 2 on July 23, 2018 revealed the laboratory had been performing this test since 1997. Personnel 2 stated he did not have any studies for the initial setup of the Lymphocyte Blastogenesis Assay. Personnel 2 stated he knew of no studies that were performed or kept. Personnel 2 stated he was unaware of the studies that need to be performed prior to patient testing. Personnel 2 confirmed the laboratory failed to have a specimen stability study performed. III. Based on observation, record review, and interview with personnel, the laboratory failed have a system in place for specimen referral for "Lymphocyte Blastogenesis Assay on Prostate Cancer Patients." Findings: 1. Observation by the surveyor during the tour of the laboratory on July 23, 2018 revealed the laboratory utilized the following equipment for processing and reading results for Lymphocyte Blastogenesis Assay : Beckman Coulter LS 6500 Liquid Scintillation Counter Skatron Basic 96 Harvester Two (2) Panasonic CO2 Incubators Nikon Microscope Olympus Microscope 2. Interview with Personnel 2 on July 23, -- 7 of 40 -- 2018 revealed the laboratory had developed a test for "Lymphocyte Blastogenesis Assay" testing which includes tumor markers for: TAA, HTA, HTA HT-29, HTA SW480, HTA HTB-38, HTA NCI-1640, HTA CRL 5833, HTA HTB58, CA 15-3, CA 125, CA 19-9, and CEA. 3. Review of the Laboratory Policy and Procedure Manual revealed a Procedure Manual For "Lymphocyte Blastogenesis Assay on Prostate Cancer Patients". Under "Specimen Collection and Preparation" a procedure for drawing patient samples and processing the sample to be sent to Laboratory 2 for testing. 4. Interviews with Personnel 1 and 2 on July 23, 2018 revealed that samples for Prostate Cancer are all referred to Laboratory 2 for testing. Personnel 1 and 2 stated that no Prostate testing is performed in house. 5. Observation by surveyor on August 2, 2018 during a tour of Laboratory 2 found no laboratory equipment or patient samples for PSA testing. 6. Interview with Laboratory 2 representative on August 2, 2018 stated no laboratory testing is performed at their facility. There was no way to determine where laboratory 1 was sending their PSA patient tests. 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 with laboratory personnel, the laboratory failed to document the date and time specimens are received into the laboratory for nine (9) of nine (9) patients reviewed. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory did not include policies and procedures for documenting the date and time for each specimen received into the laboratory. 2. Review of a random selection of Patient Test Records for "Lymphocyte Blastogenesis Assay" testing (which includes tumor markers: TAA, HTA, HTA HT-29, HTA SW480, HTA HTB-38, HTA NCI-1640, HTA CRL 5833, HTA HTB58, CA 15-3, CA 125, CA 19-9, and CEA) from July 5, 2017 through June 4, 2018 revealed the laboratory failed to document the date and time the following nine (9) patients were received into the laboratory: On June 4, 2018 Patient 1. On May 15, 2018 Patient 2. On April 19, 2018 Patient 3. On March 15, 2018 Patient 4. On February 19, 2018 Patient 5. On January 18, 2018 Patient 6. On November 28, 2017 Patient 7. On September 6, 2017 Patient 8. On July 5, 2017 Patient 9. 3. Interview with Personnel 2 on July 23, 2018 confirmed the laboratory failed to document the date and time each specimen is received into the laboratory. Review of the Task 1 and 3 Form submitted to surveyors on November 17, 2016 revealed the laboratory performed and reported the following annual volumes of testing without ensuring the time the patients specimen was received into the laboratory was documented: 9100 - Barb, 9100 - Benzo, 9100 - COC, 9100 - ETOH, 9100 - Meth, 9100 - OPI, 9100 - PCP, 9100 - THC and 9100 - Creat 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: -- 8 of 40 -- Based on record review and interview with personnel, the laboratory failed to establish detailed written instructions for the facilities the laboratory provides services for to maintain the integrity of samples and ensure accurate and reliable testing. Findings: 1. Review of the Laboratory's Policy and Procedure Manual failed to include a manual for facilities that utilize the laboratory for Bacteriology, Parasitology, Virology and Histopathology testing with detailed instructions for: (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. 2. Interview with personnel 2 on July 23, 2018 revealed the laboratory accepts samples for "Lymphocyte Blastogenesis Assay" testing (which includes tumor markers: TAA, HTA, HTA HT-29, HTA SW480, HTA HTB-38, HTA NCI-1640, HTA CRL 5833, HTA HTB58, CA 15-3, CA 125, CA 19-9, and CEA) from other locations. Personnel 2 revealed he was unaware that a Client Service Manual was required. Personnel 2 confirmed the laboratory did not have or provide a service manual to the outside facilities that they provide service to for maintaining the integrity of patient samples to ensure accurate and reliable testing. 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 written quality assessment policies and procedures for monitoring, identifying and correcting problems identified with the preanalytic system. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory failed to establish written quality assessment policies and procedure for monitoring, identifying and correcting problems identified with preanalytic systems. 2. Problems identified in the Preanalytic System found during the survey that failed to be addressed by the laboratory: a) The laboratory failed to obtain a written request from the physician for seven (7) of nine (9) patients reviewed. Refer to D5301. b) The laboratory failed maintain test requisitions that included all the required information for nine (9) of nine (9) patients. Refer to D5305. c) The laboratory failed to establish complete written policies and procedures addressing specimen submission, handling, and referral. Refer to D5311 I. d) The laboratory failed to ensure that a specimen stability study was performed to support their policy that samples for Lymphocyte Blastogenesis Assay must be processed within 48 hours of collection. Refer to D5311 II. e) The laboratory failed to document the date and time specimens are received into the laboratory for nine (9) of nine (9) patients reviewed. Refer to D5313. f) The laboratory failed to establish detailed written instructions for laboratory services provided for inpatient and outpatient testing and for maintaining the integrity of samples and ensuring accurate and reliable testing according to current manufacturers guidelines. Refer to D5317. 3. Interview with personnel 2 on July 23, 2018 revealed he was unaware of the things that needed to be monitored. Personnel 2 confirmed the above findings. D5400 ANALYTIC SYSTEMS -- 9 of 40 -- 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 observatio, 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 ensure the laboratory policy and procedure manual contained complete policies and procedures. Refer to D5401. 2. The laboratory failed to ensure the laboratory policy and procedure manual contained complete policies and procedures. Refer to D5403. 3. The laboratory failed to have the policy and procedure manual approved, signed, and dated by the Laboratory Director. Refer to D5407. 4. The laboratory failed to ensure that solutions, reagents, medium and filters are not used beyond their expiration dates. Refer to D5417. 5. The laboratory failed to establish and verify the Lymphocyte Blastogenesis Assay performed by the laboratory. Refer to D5423. 6. The laboratory failed to establish and verify performance specifications for Calibration and Quality Control procedures utilized for ensuring accurate and reliable test results for patient samples for Lymphocyte Blastogenesis Assay. Refer to D5425. 7. The laboratory failed to establish and verify performance specifications for Maintenance or Function Checks utilized for ensuring accurate and reliable test results for patient samples for Lymphocyte Blastogenesis Assay. Refer to D5427. 8. The laboratory failed to perform two levels of control materials each day of patient testing for "Lymphocyte Blastogenesis Assay" testing (which includes tumor markers: TAA, HTA, HTA HT-29, HTA SW480, HTA HTB- 38, HTA NCI-1640, HTA CRL 5833, HTA HTB58, CA 15-3, CA 125, CA 19-9, and CEA) for nine (9) of nine (9) patients reviewed. Refer to D5447. 9. The laboratory failed to establish criteria for acceptability of all control materials for each test performed by the laboratory. Refer to D5469. 10. The laboratory failed to check each batch of QBSF-56 media for sterility, and document the physical characteristics of the media when compromised and report any deterioration of the media to the manufacturer. Refer to D5477. 11. The laboratory failed to take