United Bioscience, Llc

Summary Statement of Deficiencies D0000 An unannounced investigation of complaint TX00328018 was conducted on 10/22 /2019. This facility was found NOT to be in compliance with CLIA regulations found at 42 CFR for the specialties/subspecialties in which it was surveyed. 493.1441 Laboratory Director 493.1447 Laboratory Technical Supervisor Complaint TX00328018 was substantiated. An exit conference was held on 10/22/2019 with the testing person. The exit conference attendee was advised the laboratory was out of compliance and advised of conditions and deficiencies found during the survey. On 10 /24/2019, the laboratory owner provided documentation that the laboratory has ceased testing. -------------------------------------------------------------------------------------------- 493.51 Notification requirements for laboratories issued a certificate of compliance Laboratories issued a certificate of compliance must meet the following conditions: (a) Notify HHS or its designee within 30 days of any change in-- (1) Ownership; (2) Name; (3) Location; (4) Director; or (5) Technical supervisor (laboratories performing high complexity only). (b) Notify HHS no later than 6 months after performing any test or examination within a specialty or subspecialty area that is not included on the laboratory's certificate of compliance, so that compliance with requirements can be determined. (c) Notify HHS no later than 6 months after any deletions or changes in test methodologies for any test or examination included in a specialty or subspecialty, or both, for which the laboratory has been issued a certificate of compliance. This STANDARD is not met as evidenced by: Based on review of electronic mail (email) documents and in telephone interview with the laboratory owner, the laboratory failed to notify the State Agency (SA) within 30 days of change in ownership (change occurred 04/18/2019). Findings included: 1. On 10/17/2019 at 2:32 pm, the SA received an email from United Bioscience previous owner stating, "Thank you for your recent email communications. Please note that United Bioscience LLC with CLIA #45D2114136 has transferred ownership earlier in 2019, specifically on April 18, 2019. We are not sure that the new owner provided notice to your CLIA office, however we would ask that you direct any future correspondence to the following contact (new owner): [company name, new owner name, address, telephone number and email address]. [testing person name] should still be reachable at the laboratory as well." The SA replied on 10/18/2018 at 9:38 am, asking, "I see there is a Utah Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- address, has the CLIA number moved to Utah or is there an address in the DFW area?" On 10/18/2019 at 1:02 pm, the previous owner replied stating, "The only DFW area local address that we know of is the lab address - 901 W Leuda Suite B, Fort Worth, Texas 76104. Regarding the question about moving the CLIA to Utah, I would have no knowledge of that since we have very limited communication with the new owners. It would be best to direct that question to them directly, contact info and email below in last email." The SA had never receive notification of the change in ownership with a CMS 116 application (effective 04/18/2019), within the required 30 days. The SA was made aware of the change by the previous owner 6 months later on 10/17/2019 via email. 2. During a telephone interview on 10/22/19 at 11:33 a.m., the new laboratory owner, stated that he had purchased the laboratory in 04/2019. He stated that he thought the change in ownership had been submitted to the state agency. This confirmed the above findings. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of electronic mail (email) documents, verification records, patient requisitions, patient test reports, and in interview with staff, the laboratory did not have a laboratory director to provide overall management and direction, as required. The laboratory failed to ensure a laboratory director was employed to provide oversight when patient testing occurred from 06/25/2019 through 09/30/2019 (total of 31 patients). D6078 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1443 The laboratory director must be qualified to manage and direct the laboratory personnel and performance of high complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory director must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b) (1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2) Be a doctor of medicine, a doctor of osteopathy or doctor of podiatric medicine licensed to practice medicine, osteopathy or podiatry in the State in which the laboratory is located; and (b)(2)(i) Have at least one year of laboratory training during medical residency (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (b)(2)(ii) Have at least 2 years of experience directing or supervising high complexity testing; or (b)(3) Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and-- (b)(3)(i) Be certified and continue to be certified by a board approved by HHS; or (b)(3)(ii) Before February 24, 2003, must have served or be serving as director of a laboratory performing high -- 2 of 12 -- complexity testing and must have at least-- (b)(3)(ii)(A) Two years of laboratory training or experience, or both; and (b)(3)(ii)(B) Two years of laboratory experience directing or supervising high complexity testing. (b)(4) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538, on or before February 28, 1992; or (b)(5) On or before February 28, 1992, be qualified under State law to direct a laboratory in the State in which the laboratory is located; or (b)(6) For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology, American Board of Pathology, the American Osteopathic Board of Pathology, or possess qualifications that are equivalent to those required for certification. This STANDARD is not met as evidenced by: Based on review of email documents, verification records, patient requisitions, patient test reports, and in interview with staff, the laboratory failed to ensure a laboratory director was employed to provide oversight when patient testing occurred from 06/25 /2019 through 09/30/2019 (total of 31 patients). Findings included: 1. On 10/05/2019 at 9:23 am, the SA received an email from the laboratory director, stating, "This is to inform you that I have resigned from United Bioscience laboratory effective April 16 2019 [sic]. I no longer work there and would like CLIA to make a note of the same. Please direct all future communication to [testing person name] at United Bioscience." 2. On 10/07/2019 at 10:49 am, the SA sent an email to the testing person, stating, "We received notification from the lab director that they resigned in April. Please submit a CMS 116 form with the current lab director." The SA never received a response and did not receive a CMS 116 application designating the new laboratory director. 3. On 10/18/2019 at 9:33 am, the SA sent an email to the new owner (effective date 04/18 /19) stating, "I was given your contact [previous owner name] former owner of United BioScience. He stated that Aperture Medical, LLC purchased United BioScience 45D2114136 on April 18, 2019. Please call me as soon as possible to discuss this matter. My office number is below." The SA never received a response and did not receive a CMS 116 application designating the new laboratory director. On 10/21 /2019 at 9:38 am, the SA sent a second email to the new owner, stating, "This is the second email attempt to reach you. I have called the number provided by [previous owner name] former owner of United Bioscience and have left two messages as well. Please return my call promptly. I have also called and emailed the laboratory. I have left messages as well with no return call or email." The SA never received a response and did not receive a CMS 116 application designating the new laboratory director. 4. During a telephone interview on 10/22/19 at 11:33 a.m., the new laboratory owner, stated that he had purchased the laboratory in 04/2019. He stated that the laboratory director was supposed to stay on as the laboratory director when the sale occurred. He stated that he found out on 10/07/2019 that the laboratory director had resigned on 04 /16/2019. He stated that the resignation date had been back dated by the laboratory director. He also stated that he has been trying to find a laboratory director to replace the previous laboratory director. He stated that facility has been running specimens from the previous owner's private practice. He stated that he planned to close the laboratory at the end of the month (10/2019). 5. During the onsite complaint investigation on 10/22/2019 at 2:00 pm, the testing person provided the surveyors documentation of emails exchanged between him and the laboratory director. Review of the email exchange was dated 06/21/2019 and included an attachment signed and dated (06/20/2019) by the laboratory director titled: "Laboratory Validation of a Quantitative Assay" (pH) for the Beckman Coulter AU480. The signed document was in a binder for "Beckman Coulter AU480 CEDIA and DRI DAU Assay Validation; -- 3 of 12 -- Validated by: [testing person name]; Title: Director of Lab Services; Date: Week of OCTOBER 08, 2018; Serial #: 20160140092; System ID: 24794335." The laboratory director had stated her last day was 04/16/2019, yet signed a verification study on 06 /20/2019. 6. Further review revealed the laboratory had been testing patient urine specimens for drugs of abuse and adulterants on the Beckman Coulter AU480 without a laboratory director. Review included patient test requisitions and final test reports from 06/25/2019 through 09/30/2019, as follows: Patient #190624001 specimen was collected 06/24/2019 and tested 06/25/2019 Patient #190624003 specimen was collected 06/24/2019 and tested 06/25/2019 Patient #190624002 specimen was collected 06/24/2019 and tested 06/25/2019 Patient #190628002 specimen was collected 06/26/2019 and tested 06/28/2019 Patient #190628004 specimen was collected 06/26/2019 and tested 06/28/2019 Patient #190628003 specimen was collected 06/26/2019 and tested 06/28/2019 Patient #190628005 specimen was collected 06/27/2019 and tested 06/28/2019 Patient #190628001 specimen was collected 06/28/2019 and tested 06/28/2019 Patient #190724001 specimen was collected 07/24/2019 and tested 07/25/2019 Patient #190730001 specimen was collected 07/29/2019 and tested 07/30/2019 Patient #190730002 specimen was collected 07/29/2019 and tested 07/30/2019 Patient #190805001 specimen was collected 07/31/2019 and tested 08/05/2019 Patient #190805003 specimen was collected 08/02/2019 and tested 08/05/2019 Patient #190805002 specimen was collected 08/02/2019 and tested 08/05/2019 Patient #190805004 specimen was collected 08/02/2019 and tested 08/05/2019 Patient #190806002 specimen was collected 08/05/2019 and tested 08/06/2019 Patient #190806001 specimen was collected 08/05/2019 and tested 08/06/2019 Patient #190830003 specimen was collected 08/28/2019 and tested 08/30/2019 Patient #190830002 specimen was collected 08/28/2019 and tested 08/30/2019 Patient #190830001 specimen was collected 08/29/2019 and tested 08/30/2019 Patient #190830004 specimen was collected 08/29/2019 and tested 08/30/2019 Patient #190903003 specimen was collected 08/30/2019 and tested 09/04/2019 Patient #190903002 specimen was collected 08/30/2019 and tested 09/04/2019 Patient #190903001 specimen was collected 08/30/2019 and tested 09/04/2019 Patient #190927002 specimen was collected 09/24/2019 and tested 09/27/2019 Patient #190927001 specimen was collected 09/24/2019 and tested 09/27/2019 Patient #190927005 specimen was collected 09/25/2019 and tested 09/27/2019 Patient #190927004 specimen was collected 09/26/2019 and tested 09/27/2019 Patient #190927003 specimen was collected 09/26/2019 and tested 09/27/2019 Patient #190930002 specimen was collected 09/27/2019 and tested 09/30/2019 Patient #190930001 specimen was collected 09/27/2019 and tested 09/30/2019 The patients mentioned above were all tested for: Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cannabinoids (THC), Cocaine, Ecstasy (MDMA), Ethyl Alcohol, Methadone, Opiates, Oxycodone, Phencyclidine (PCP), Propoxyphene, and adulterants pH, Oxidants, and Creatinine. 6. During an interview on 10/22/19 at 2:00 p.m., the testing person, stated that the last time he had any communication with the laboratory director was on 06/21/2019 when she returned a signed verification study via email. He stated that he had attempted to contact the laboratory director via phone and text messages on numerous occasions and she was not returning any messages. He stated that the change in ownership occurred in April or May of 2019 and he did not have any of those documents. He stated that he found out about the laboratory director's resignation when the state agency contacted him to ask about her resignation on 10/07 /2019. He stated that he contacted the new owner via email to inform him of her resignation. He stated that the laboratory has been testing urine toxicology specimens. The last specimens received in the laboratory for testing was on 09/30/2019. He stated that to his knowledge the laboratory director never submitted a letter of resignation. 7. -- 4 of 12 -- On 10/22/2019 at 5:21 pm, the SA sent an email to the laboratory director asking, " Do you have any documentation (email/letter, etc.) of your resignation to the previous or new owner?" There was no reply. On 10/24/2019 at 3:55 pm, the SA sent a second email to the laboratory director stating, "We are trying to obtain an accurate date of your resignation. We have documentation from United Bioscience that includes an email exchange between you and the testing person for signing a verification study on 06/21/19 and the pH verification document with your signature/date from 06/20/19 (see attachments). In order to determine the action that will be taken on the laboratory, an accurate date is essential. If you have something in writing that was provided to the lab about your resignation that would be helpful or a more accurate date. Thank you, ..." On 11/18/2019 at 9:59 am, the laboratory director replied via email, stating, "My apologies for the delay in response as I was out of country due to...Attached is the letter of resignation. I have effectively resigned April 16th, 2019 from United Biosciences Lab. I have received no salary since or after that date. As for the letter on 6/20/19. That was just done as a courtesy to help the previous owners of United Biosciences out for that one last time. I have had no communication after that or intend having any more contact with the laboratory." The letter attached to the email stated, "Dear [previous owner name], As per our verbal conversation, I am unable to work as Medical Director of United Bioscience due to...This letter is to confirm my resignation effective April 16th 2019 ..." The laboratory director was involved with the laboratory until 06/21/2019 based on signed/approved verification studies cleared for testing (a laboratory director responsibility). The laboratory did not ensure a laboratory director was employed to provide oversight when patient testing occurred from 06/25/2019 through 09/30/2019. D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: Based on review of the laboratory's CMS 209 from the initial survey, personnel records, email documentation, and in interview with staff, the laboratory did not have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision. The laboratory did not employ a technical supervisor (TS) who meets qualifications to provide technical oversight of high complexity testing, as required by a directed

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative at the entrance and exit conferences. The facility representatives were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. Based upon the onsite survey conducted 12/17/2018 - 12/19/2018 this facility was found NOT to be in compliance with the CLIA regulations found at 42 CFR for the specialties/subspecialties in which it was surveyed. 493.1240 Pre-Analytic Systems 493.1250 Analytic Systems 493.1409 Technical Consultant 493.1441 Laboratory Director, (high complexity) 493.1447 Technical Supervisor 493.1459 General Supervisor D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the CMS 209, personnel records, proficiency testing (PT) records, and in interview with staff, the laboratory failed to ensure PT samples were tested by personnel who routinely perform Allergy testing on the Hitachi CLA - 1 test method for 2 of 3 testing events in 2017 (2017-B, 2017-C) and 2 of 3 testing events in 2018 (2018-A, 2018-B). Findings included: 1. Review of the CMS 209 form listed two testing persons (TP-1 and TP-2) who perform high complexity testing, that included allergy testing on the Hitachi CLA-1. Review of personnel records revealed TP-1 hire date was 07/10/2017 and TP-2 hire date was 08/10/2017. Training documentation for allergy testing for both TP's was in 07/2017 and 08/2017. 2. Review of PT records for allergy testing for 2017 and 2018 revealed the following events were all tested by TP- 1: 2017 Event SE-B testing date was 09/01/2017 2017 Event SE-C testing date was 12 /07/2017 2018 Event SE-A testing date was 04/09/2018 2018 Event SE-B testing date Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 61 -- was 08/23/2018 The laboratory did not ensure PT samples were tested by personnel who routinely perform Allergy testing on the Hitachi CLA - 1 test method. 3. During an interview on 12/17/2018 at 12:30 pm, TS (who was also TP-1) reviewed the above findings and stated TP-2 helps set-up the PT samples for testing. The did not ensure PT samples were tested by TP-2, who routinely performs Allergy testing on the Hitachi CLA - 1 test method. Word Key: SE - southeastern (southeastern inhalants) 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: I. Based on direct observation, review of laboratory records and confirmed in interview, the laboratory failed to retain package inserts for 6 of 12 sets of urine toxicology control material. Findings included: 1. Observed in the laboratory refrigerator on 12/18/2018 at 1540 hours were the following urine toxicology quality control materials in use: a. MAS DOA Total Control One vial of Level 2 MAS DOA Total Control Lot number DAT18122A/Expiration Date 2018-12-31 One vial of Level 3 MAS DOA Total Control Lot number DAT18123A/Expiration Date 2018-12- 31 One vial of Level 4 MAS DOA Total Control Lot number DAT18124A/Expiration Date 2018-12-31 One vial of Level 5 MAS DOA Total Control Lot number DAT18125A/Expiration Date 2018-12-31 b. MGC Select XTC Control: One vial of Low Level MGC Select XTC Control Lot number 730233349/Expiration Date 2020 /01 One vial of High Level MGC Select XTC Control Lot number 730233350 /Expiration Date 2020/01 c. DRI Hydrocodone Assay Control: One vial of Low Level DRI Hydrocodone Assay Control Lot number 73122350/Expiration Date 2019/08 One vial of Low Level DRI Hydrocodone Assay Control Lot number 73122351 /Expiration Date 2019/08 d. CEDIA Buprenorphine Control One vial of Low Level CEDIA Buprenorphine Control Lot number 73008237/Expiration Date 2019/08 One vial of High Level CEDIA Buprenorphine Control Lot number 73008238/Expiration Date 2019/08 e. Creatinine Detect Control: One vial of Creatinine Detect 1.3 Control Lot number 73079519/Expiration Date 2018/12 One vial of Creatinine Detect 7.5 Control Lot number 73079520/Expiration Date 2018/12 One vial of Creatinine Detect 23.0 Control Lot number 73079543/Expiration Date 2018/12 f. DRI General Oxidant- Detect Control One vial of Low Level DRI General Oxidant-Detect Control Lot number 73181372/Expiration Date 2019/09 One vial of High Level DRI General Oxidant-Detect Control Lot number 73181373/Expiration Date 2019/09 2. Review of laboratory records revealed a document titled "Lots Used for Toxicology Validation 7- 10-16" listed the following urine toxicology control material lot numbers: MAS DOA Total L2; Lot number DAT17072A; Expiration date 7-31-17 MAS DOA Total L3; Lot number DAT18023A; Expiration date 2-28-18 MAS DOA Total L4; Lot number DAT17074A; Expiration date 7-31-17 MAS DOA Total L5; Lot number DAT17075A; Expiration date 7-31-17 MGC Select DAU Control Set; Lot number 72371641; Expiration date 11-30-17 MGC Select DAU High Control; Lot number 72371649; Expiration date 11-30-17 DRI Hydrocodone Low Control; Lot number 72329751; Expiration date 5-31-2017 DRI Hydrocodone High Control; Lot number 72329745; Expiration date 5-31-2017 Cedia Buprenorphine Low Control; Lot number 72428405; Expiration date 9-30-17 Cedia Buprenorphine High Control; Lot number 72428406; Expiration date 9-30-17 Creatinine Detect 1.3 mg/dl Control; Lot number -- 2 of 61 -- 72363194; Expiration date 1-31-17 Creatinine Detect 7.5 mg/dl Control; Lot number 72363192; Expiration date 1-31-17 Creatinine Detect 23.0 mg/dl Control; Lot number 72363190; Expiration date 1-31-17 DRI General Oxidant Detect Negative Control; Lot number 72372818; Expiration date 5-31-17 DRI General Oxidant Detect Positive Control; Lot number 72372822; Expiration date 5-31-17 3. During an interview on 12 /18/2018 at 1540 hours, the laboratory manager was asked to provide package inserts for previous lot numbers of urine toxicology control material. He stated the current lots of control material were in use when he started working at the facility and he was not aware of any past lot numbers that were utilized. After reviewing the document titled "Lots Used for Toxicology Validation 7-10-16", the laboratory manager confirmed the package inserts for the above reagents were not retained. This confirmed the above findings. 40420 Surveyor: 40420 II. Based on review of laboratory records and confirmed in interview, the laboratory failed to ensure instrument print outs (thermal paper) from the Hitachi analyzer were properly retained for quality control (QC) for 5 of 5 days in 2017 (08/2017, 09/2017 random sampling) and 9 of 9 patient test results in 2017 and 2018 (10/2017, 10/2018 random sampling). Findings: 1. Review of the Hitachi analyzer instrument print outs (thermal paper) for quality control and patient test results revealed the laboratory failed to ensure the thermal paper remained legible. The following is a random sampling for 2017 and 2018: Southeastern inhalants, test date 08/18/2017 (from planner sheet) Positive control lot #K4K34895, Exp. Date 01/31/2019, test date and time were illegible on the thermal paper Negative control lot #A1273-156K, Exp. Date 02/28/2019, test date and time were illegible on the thermal paper Southeastern inhalants, test date 09/01/2017 (from planner sheet) Positive control lot # unknown (it was not documented), test date and time were illegible on the thermal paper Negative control lot # unknown (it was not documented), test time was illegible on the thermal paper Moderate food, test date 09/01/2017 (from planner sheet) Negative control lot # unknown (it was not documented), test time was illegible on the thermal paper Moderate food, test date 09 /13/2017 (from planner sheet) Positive control lot #K4K34895, Exp. Date 01/2019, test year, test time, analyte # 24 LU value and name, apple analyte LU value, and analyte #26 LU value and name were illegible on the thermal paper Negative control lot #A1273-156K, Exp. Date 02/2019, test year, test time, analytes #25 and 26 names were illegible on the thermal paper Southeastern inhalants, test date 09/13/2017 (from planner sheet) Positive control lot #K4K34895, Exp. Date 01/2019, test date and time were illegible on the thermal paper Negative control lot #A1273-156K, Exp. Date 02 /2019, test date, test time and name of analyte #36 were illegible on the thermal paper Patient 180917001 tested for inhalants on 10/23/18 (from planner sheet), year of testing was illegible on the thermal paper only month and day (Oct 23) Patient 181008007 tested for inhalants on 10/23/18 (from planner sheet), day of testing was illegible on the thermal paper only month and year (Oct 2018) Patient 181008005 tested for inhalants on 10/23/18 (from planner sheet), day of testing was illegible on the thermal paper only month and year (Oct 2018) Patient 181008001 tested for inhalants on 10/23/18 (from planner sheet), day of testing was illegible on the thermal paper only month and year (Oct 2018) Patient 181008002 tested for inhalants on 10/23 /18 (from planner sheet), day of testing was illegible on the thermal paper only month and year (Oct 2018) Patient 180904010 tested for food on 10/23/18 (from planner sheet), month and year of testing were illegible on the thermal paper Patient 170929003 tested for inhalants on 10/04/2017, test time and name of analyte #36 were illegible on the thermal paper Patient 170929002 tested for inhalants on 10/04/2017, analyte #36 Penicillium LU value was illegible on the thermal paper Patient 170929004 tested for inhalants on 10/07/17 (from planner sheet), date of testing, analytes #35 and 36 names and LU values were illegible on the thermal paper only month and year (Oct 2018) The laboratory failed to ensure instrument print outs -- 3 of 61 -- (thermal paper) from the Hitachi analyzer were properly retained for QC and patient test results. 2. During the exit interview on 12/19/2018 at 12:32 pm, Testing Person-1 and Testing Person-2 confirmed the above findings. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) records and in interview with staff, the laboratory failed to retain all PT documents for allergy testing for 1 of 3 testing events in 2017 (2017-A). Findings included: 1. Review of PT records from 2017 for allergy testing performed on the Hitachi CLA-1 analyzer revealed the laboratory did not retain the instrument printouts for PT samples tested for 2017 Event SE-A. PT samples (SE-01, SE-02, SE-03, SE-04, SE-05) were tested/reported for southeastern inhalants and raw data was not retained. Testing date was not available and attestation was signed/dated 05/24/2017 by a prior testing person. 2. During an interview on 12 /17/2018 at 12:30 pm, the technical supervisor reviewed the above findings and was unable to provide. The laboratory did not retain all PT records, as required. 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 review of CMS 209 form, personnel records, and in interview with staff, the laboratory failed to establish and follow written policies to assess consultant competency for 1 of 1 technical consultant (TC), technical supervisor (TS), and general supervisor (GS) in 2018 (01/2018). Findings included: 1. Review of the CMS 209 form included one individual listed as the TC, TS, and GS to provide oversight of chemistry testing, urine drug screen testing on AU480 analyzer, and allergy testing on the Hitachi CLA-1 analyzer. 2. Personnel records for the TC/TS/GS revealed hire date was 07/10/2017 and initial training was documented in 07/2017 for testing on the AU480 and Hitachi CLA-1. There was no documentation of competency assessment at least semi-annually during the first year the individual was employed and testing. There were no policies/procedures established for assessing TC/TS/GS competency and no written delegated duties as specified by the laboratory director (Refer to D6103 and D6107). The laboratory did not ensure competency assessment was performed and documented for the TC/TS/GS individual. 3. During an interview on 12 /17/2018 at 11:10 am, the TS was unable to provide the above requested documentation. II. Based on review of laboratory policy, laboratory record, and personnel records, the laboratory failed to include allergy testing in their personnel competency assessment policy. Findings included: 1. Review of the laboratory's policy "Personnel Competency Check" only included the specialty chemistry in their personnel assessment policy/procedure (approval by laboratory director date: 02/05 /2016). 2. According to records, the laboratory implemented allergy testing by Hitachi CLA-1 method 02/2017. The annual volume was 42,000 allergy tests performed. 3. -- 4 of 61 -- Review of personnel records revealed the technical supervisor had not evaluated and documented competency assessment for TP-2 at least semiannually (02/2018). Refer to D6127. The laboratory's policy did not include allergy testing (Immunology) in their personnel competency assessment policy. 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: I. Based on review of College of American Pathologist (CAP) proficiency testing (PT) records, laboratory's procedure manual, and in interview with staff, the laboratory failed to at least twice annually verify accuracy of drug analytes and adulterants tested on the AU480 not included in subpart I of this part and not covered by the PT company in 2017 and 2018. Findings included: 1. Review of CAP PT records for urine drug screen testing on the AU480 revealed ecstasy was only included in 1 of 3 testing events in 2017 (2017 Event -A). The laboratory did not ensure ecstasy was verified for accuracy at least twice annually in 2017. 2. Review of CAP PT record for urine drug screen testing on the AU480 revealed hydrocodone was not included in 3 of 3 testing events in 2017 and 2018. During an interview on 12/17/2018 at 12:30 pm, the TS stated split sample testing was performed with another laboratory to cover hydrocodone. Documentation was provided and revealed the split sample testing with the other laboratory was done 12/10/2018 (this included hydrocodone). The laboratory did not ensure hydrocodone was verified for accuracy at least twice annually in 2017. Hydrocodone was verified for accuracy only once in 2018, not twice. 3. Review of CAP PT records for urine drug adulterants testing on the AU480 revealed creatinine was only included in 1 of 2 testing events in 2018 (2018 Event - A). There was no PT records or other twice annual verification of accuracy documentation in 2017 for creatinine. The laboratory did not ensure creatinine was verified for accuracy at least twice annually in 2017 and 2018. 4. Review of the laboratory's procedure manual did not include a policy/procedure for split sample testing for analytes not covered in the subpart I of this part (non-regulated analytes) to verify accuracy. Refer to D5403. 5. During an interview on 12/17/2018 at 12:30 pm, the TS reviewed and confirmed the above findings. II. Based on review of laboratory's allergy panels, proficiency testing (PT) records, and in interview with staff, the laboratory failed to at least twice annually verify accuracy of all allergy subgroups tested on the Hitachi CLA-1 not included in subpart I of this part and not covered by the PT company in 2017 and 2018. Findings included: 1. Review of laboratory's records revealed Hitachi CLA-1 analyzer was implemented 02/2017. Subgroups Southeastern Inhalants and Moderate Food allergy panels were tested. 2. Review of proficiency testing (PT) records from 2017 and 2018 for Allergy testing revealed not all subgroups were covered in PT to ensure verification of accuracy, at least twice annually, as follows: 2017 Event SE-A analyzed Southeastern Inhalants and not Moderate Food 2017 Event SE-B analyzed Southeastern Inhalants and not Moderate Food 2018 Event SE-A analyzed Southeastern Inhalants and not Moderate Food 2018 Event SE-B analyzed Southeastern Inhalants and not Moderate Food 2018 Event SE-C analyzed Southeastern Inhalants and not Moderate Food The laboratory failed to ensure verification of accuracy, at least twice annually for Moderate Food allergy panel subgroup. 3. During an interview on 12/17/2018 at 2:13 pm, the Technical Supervisor (TS) was asked whether the laboratory had any other documentation of verification of -- 5 of 61 -- accuracy for Allergy testing, he stated he had sent a sample to Allos (laboratory affiliated with manufacturer) but was having problems with it. The TS was asked whether sending a sample to Allos was sent on a defined frequency/schedule, he stated no. There was no written policy for this practice. 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 direct observation, laboratory policies, a random review of Beckman Coulter AU 480 urine toxicology analyzer patient test records from 03/03/2017 through 12/12/2018, manufacturer's instructions, patient test reports, client services manual, test requsitions, Thermo Scientific DRI urine assay manufacturer's instructions, laboratory's documents, and confirmed in interview, the laboratory failed to meet the requirements of the condition of preanalytical systems as evidenced by: 1. The laboratory failed to ensure the test requisitions solicited the tests to be performed for 8 of 29 requisitions. Refer to D5305. 2. The laboratory failed to follow its own written policy and manufacturer instructions for testing specimens for urine toxicology analytes within the specified stability requirements for 13 of 67 patients from 03/03/2017 through 12/12/2018. Refer to D5311, I. 3. The laboratory failed to ensure the correct specimen storage, preservation and conditions for transportation, according to manufacturer's instructions for 11 of 11 specimens in 2017 (random sampling). Refer to D5311, II. 4. The laboratory failed to establish a policy for the rejection of hemolyzed specimens used in allergy testing. Refer to D5311, III. 5. The laboratory failed to document the time 67 of 67 patient specimens were received into the laboratory for processing and testing. Refer to D5313, I. 6. The laboratory failed to document the received time of specimens that were received from outside clients for 60 of 60 patients in 2017 (06/2017, 07/2017, 08/2017, 09/2017, 10/2017, 12/2017) and 10 of 10 patients 2018 (08/2018, 09/2018, 10/2018) for allergy testing. Refer to D5313, II. 7. The laboratory failed to ensure all components for proper handling of urine specimens were included in their client services document. Refer to D5317, I. 8. The laboratory failed to ensure the client services manual was consistent with manufacturer's instructions for specimen handling for allergy specimens that were received from clients. Refer to D5317, II. 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 -- 6 of 61 -- 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 review of laboratory policy, a random review of Beckman Coulter AU 480 urine toxicology analyzer patient test records from 03/03/2017 through 12/12/2018, and staff interview, the laboratory failed to ensure the test requisitions solicited the tests to be performed for 8 of 29 requisitions. Findings included: 1. The laboratory policy titled "Patient Test Management - Specimen Accessioning and Processing" (approved by the Laboratory Director 10/05/2016) stated, "Select the laboratory tests or profiles requested by the physician for which appropriate samples have been received." 2. Review of patient test requisitions revealed the following requisitions with NO tests requested: Date 03/03/2017; Patient Number 170303001 Date 07/11 /2017; Patient Number 170711001 Date 07/11/2017; Patient Number 170711002 Date 11/16/2017; Patient Number 171116001 Date 10/26/2018; Patient Number 181026001 Date 10/26/2018; Patient Number 181026002 Date 10/26/2018; Patient Number 181026003 Date 12/11/2018; Patient Number 181211002 3. The above findings were confirmed in an interview by the laboratory staff on 12/18/2018 at 1550 hours in the conference room. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: I. Based on review of the laboratory policy, manufacturer's instructions, review of laboratory records, review of patient test reports, and confirmed in staff interview, the laboratory failed to follow its own written policy and manufacturer instructions for testing specimens for urine toxicology analytes within the specified stability requirements for 13 of 67 patients from 03/03/2017 through 12/12/2018. Findings included: 1. Review of the laboratory policies for Barbiturates, Buprenorphine, Cannabinoid, Ethyl Alcohol, Opiate, and Hydrocodone approved by the laboratory director on 10/5/2016 specified the following in the section titled "Specimen Collection and Handling": a. Barbiturates "Specimens kept at room temperature that do not receive initial test within 7 days of arrival at the laboratory may be placed in a secure refrigeration unit at 2 to 8C (Celsius) for up to 7 days." b. Buprenorphine "Specimens kept at room temperature that do not receive initial test within 8 days of arrival at the laboratory may be placed in a secure refrigeration unit at 2 to 8C (Celsius) for up to 30 days." c. Cannabinoid "Specimens kept at room temperature that do not receive initial test within 7 days of arrival at the laboratory may be placed in a secure refrigeration unit at 2 to 8C (Celsius) for up to 4 weeks (28 days)." d. Ethyl -- 7 of 61 -- Alcohol "Specimens kept at room temperature that do not receive initial test within 7 days of arrival at the laboratory may be placed in a secure refrigeration unit at 2 to 8C (Celsius) for up to two months." e. Hydrocodone "Specimens kept at room temperature that do not receive initial test within 7 days of arrival at the laboratory may be placed in a secure refrigeration unit at 2 to 8C (Celsius) for up to two months." f. Opiate "Specimens kept at room temperature that do not receive initial test within 7 days of arrival at the laboratory may be placed in a secure refrigeration unit at 2 to 8C (Celsius) for up to two months." 2. The manufacturer's instructions (Thermo Scientific DRI assays) for Barbiturates, Buprenorphine, Cannabinoid, Ethyl Alcohol, Opiate, and Hydrocodone specified the following in the section titled "Specimen Collection and Handling": a. Barbiturates (0353-12-EN 2017 11) "Specimens kept at room temperature that do not receive initial test within 7 days of arrival at the laboratory may be placed in a secure refrigeration unit at 2 to 8 C (Celsius) for up to 7 days." b. Buprenorphine (10007988-13-EN 2018 01) "Specimens kept at room temperature that do not receive initial test within 8 days of arrival at the laboratory may be placed in a secure refrigeration unit at 2 to 8C (Celsius) for up to 30 days." c. Cannabinoid (0142-10-EN 2017 12) "Specimens kept at room temperature that do not receive initial test within 7 days of arrival at the laboratory may be placed in a secure refrigeration unit at 2 to 8C (Celsius) for up to 4 weeks (28 days)." d. Ethyl Alcohol (0318-11-EN 2017 12) "Specimens kept at room temperature that do not receive initial test within 7 days of arrival at the laboratory may be placed in a secure refrigeration unit at 2 to 8C (Celsius) for up to two months." e. Hydrocodone (10020160-1 2017 07) "Specimens kept at room temperature that do not receive initial test within 7 days of arrival at the laboratory may be placed in a secure refrigeration unit at 2 to 8C (Celsius) for up to two months." f. Opiate (0140-13-EN 2017 07) "Specimens kept at room temperature that do not receive initial test within 7 days of arrival at the laboratory may be placed in a secure refrigeration unit at 2 to 8C (Celsius) for up to two months." 3. Review of the laboratory records revealed the laboratory failed to establish performance specification studies for specimen collection and handling when the laboratory modified the manufacturer's stated specimen collection and handling requirements. The laboratory was asked to provide documentation of performing the studies. No documentation was provided. Refer to D5423 II 5. Review of patient test reports from 03/03/2017 through 12/12/2018 revealed the following urine toxicology analytes were tested for each patient sample: Amphetamine Barbiturate Benzodiazepine Buprenorphine Cannabinoid Cocaine Ethyl Alcohol Ecstasy Methadone Hydrocodone Opiates Oxycodone Phencyclidine Propoxyphene 4. Further review of patient test reports from 03/03/2017 through 12/12 /2018 revealed the laboratory failed to follow its own policy and Thermo Scientific DRI assay manufacturer's instructions for specified stability requirements for the following 13 of 67 patients tested: Patient 170303001 Collection Date: 02/20/2017 Receive Date: 03/03/2017 Test Date: 03/08/2017 Days Elapsed from collection to testing=16 days Specimen Tested for Barbiturate beyond the manufacturer's specified 7 days. Patient 17071200 Collection Date: 04/25/2017 Receive Date: 04/25/2017 Test Date: 07/12/2017 Days Elapsed from collection to testing =78 Days; Specimen tested for Barbiturate beyond the manufacturer's specified 7 days. Specimen tested for Buprenorphine beyond the manufacturer's specified 30 days. Specimen tested for Cannabinoid beyond the manufacturer's specified 28 days. Specimen tested for Ethyl Alcohol beyond the manufacturer's specified 2 months. Specimen tested for Hydrocodone beyond the manufacturer's specified 2 months. Specimen tested for Opiates beyond the manufacturer's specified 2 months. Patient 170712001 Collection Date: 05/25/2017 Receive Date: 07/12/2017 Test Date: 07/12/2017 Days Elapsed from collection to testing = 48 Days Specimen tested for Barbiturate beyond the manufacturer's specified 7 days. Specimen tested for Buprenorphine beyond the -- 8 of 61 -- manufacturer's specified 30 days. Specimen tested for Cannabinoid beyond the manufacturer's specified 28 days. Patient 170711002 Collection Date: 06/20/2017 Receive Date: 06/20/2017 Test Date: 07/12/2017 Days Elapsed from collection to testing= 22 Days Specimen tested for Barbiturate beyond the manufacturer's specified 7 days. Patient 170711003 Collection Date: 06/20/2017 Receive Date: 06/20/2017 Test Date: 07/12/2017 Days Elapsed from collection to testing= 22 Days Specimen tested for Barbiturate beyond the manufacturer's specified 7 days. Patient 170711004 Collection Date: 06/19/2017 Receive Date: 06/19/2017 Test Date: 07/12/2017 Days Elapsed from collection to testing= 23 Days Specimen tested for Barbiturate beyond the manufacturer's specified 7 days. Patient 170711001 Collection Date: 06/22/2017 Receive Date: 06/22/2017 Test Date: 07/12/2017 Days Elapsed from collection to testing= 20 Days Specimen tested for Barbiturate beyond the manufacturer's specified 7 days. Patient 171116001 Collection Date: 11/16/2017 Receive Date: 11/16/2017 Test Date: 11/28/2017 Days Elapsed from collection to testing= 12 Days Specimen tested for Barbiturate beyond the manufacturer's specified 7 days. Patient 1810118002 Collection Date: 01/01/2018 Receive Date: 01/18/2018 Test Date: 01/18/2018 Days Elapsed from collection to testing= 17 Days Specimen tested for Barbiturate beyond the manufacturer's specified 7 days. Patient 181009002 Collection Date: 09/24/2018 Receive Date: 10/09/2018 Test Date: 10/09/2018 Days Elapsed from collection to testing= 15 Days Specimen tested for Barbiturate beyond the manufacturer's specified 7 days. Patient 181009004 Collection Date: 09/24/2018 Receive Date: 10/09/2018 Test Date: 10/09/2018 Days Elapsed from collection to testing= 15 Days Specimen tested for Barbiturate beyond the manufacturer's specified 7 days. Patient 181009001 Collection Date: 09/25/2018 Receive Date: 10/09/2018 Test Date: 10/10/2018 Days Elapsed from collection to testing= 15 Days Specimen tested for Barbiturate beyond the manufacturer's specified 7 days. Patient 181009003 Collection Date: 09/25/2018 Receive Date: 10/09/2018 Test Date: 10/09/2018 Days Elapsed from collection to testing= 14 Days Specimen tested for Barbiturate beyond the manufacturer's specified 7 days. 5. The above findings were confirmed in an interview with the laboratory staff on 12/18/2018 at 1550 hours in the conference room. 40420 II. Based on direct observation, review of manufacturer's instructions, laboratory policies, client services manual, and confirmed in interview, the laboratory failed to ensure the correct specimen storage, preservation and conditions for transportation, according to manufacturer's instructions for 11 of 11 specimens in 2017 (random sampling). Findings: 1. Review of Hitachi CLA-1 allergy analyzer manufacturer's instructions "4 Test Operation" page 4-3 stated: "Store Serum Store serum samples at 2-8 for a period of up to one week. For longer storage, samples should be frozen at -20C. Repeated freezing and thawing of serum samples should be avoided. Storage in a frost-free refrigerator may affect the long-term stability of the sample." 2. Review of laboratory policy "CLA Allergen-Specific IgE Assay" page 3 stated "Specimen Collection and Handling ...Serum samples may be stored at 2-8C for up to one week. For longer periods up to one year, store samples frozen at -20C. Repeated freezing and thawing of serum samples should be avoided." 3. Review of laboratory policy "PRE AND POST-ANALYTICAL SAMPLE PROCESSING" stated: "SPECIMEN TRANSPORT 1. Couriers will be provided with three types of specimen transport containers: a. cooler with ice packs for refrigerated specimens. b. cooler with dry ice for frozen specimens. c. plastic box or container for non-refrigerated or non-frozen specimens." 4. Review of the laboratory client services manual "BLOOD COLLECTION FOR ALLERGY TESTING" page 2 stated: "5 PUT all allergy specimens that are packaged for shipment in specimen and keep refrigerated until ready to ship. When ready to ship, place allergy specimens in a mailing cooler along with 2-3 ice packs. WARNING DO NOT FREEZE" Client services manual was not consistent with the laboratory's policy for transport. 5. During an interview on 12/18 -- 9 of 61 -- /18 at 1:55 pm, with Testing Person-1 (TP-1) and Testing Person-2 (TP-2), the surveyor asked where specimens that were waiting to be tested were stored and TP-1 stated the freezer and pointed in the direction of the "Hot Point" frost-free refrigerator /freezer. Testing personnel were asked how the allergy specimens arrived and TP-2 stated "they come frozen on ice packs in foam coolers." TP-1 stated "2-8C is acceptable" and the specimens arrive "frozen or slushy." Testing personnel were asked how specimens were stored if they were not going to be tested the same day they were received, TP-2 stated that they would freeze them (in a "Hot Point" frost-free freezer). Testing personnel were asked if they documented the disposition of specimen arrival and TP-2 stated that it was not documented. The laboratory failed to ensure the proper storage, preservation and transportation of specimens. The freezer in which specimens were stored until testing was frost-free, this was not according to manufacturer's instructions for storage. The frost-free freezer does not maintain -20C or colder. The following are a random sampling of samples stored in the frost-free freezer; the diposition of these samples was not documented upon arrival and were not transported in conditions to ensure manufacturer's requirements were met: Patient #170726007: collection date 07/24/2017, collection time 4:00 pm, received date 07/26/207 (note received time was not documented), southeastern inhalants test date 08/02/2017, test time 14:38 Patient #170726008: collection date 07/21/2017, collection time 10:00, received date 07/26/2017 (note received time was not documented), southeastern inhalants and moderate food test date 08/02/2017, test time 14:40 (inhalants)/14:46 (food) Patient #170726009: collection date 07/19/2017, collection time 12:15, received date 07/26/2017 (note received time was not documented), southeastern inhalants test date 08/02/2017, test time 14:41 Patient #170726011: collection date 07 /21/2017, collection time 3:00, received date 07/26/2017 (note received time was not documented), southeastern inhalants test date 08/02/2017, test time 14:43 Patient #170929004: collection date 09/26/2017, collection time 3:00, received date 09/29 /2017 (note received time was not documented), southeastern inhalants test date 10/04 /2017, test time unknown due to thermal tape being illegible Patient #170929002: collection date 09/26/2017, collection time 3:00, received date 09/29/2017 (note received time was not documented), southeastern inhalants test date 10/04/2017, test time 13:49 Patient #170929003: collection date 09/22/2017, collection time 11:00 am, received date 09/29/2017 (note received time was not documented), southeastern inhalants test date 10/04/2017, test time unknown due to thermal tape being illegible Patient #171005005: collection date 10/05/2017, collection time 3:00, received date 10 /05/2017 (note received time was not documented), southeastern inhalants and moderate food test date 10/10/2017, test time unknown due to thermal tape being illegible for both inhalants and food Patient #171005006: collection date 10/05/2017, collection time 3:00, received date 10/05/2017 (note received time was not documented), southeastern inhalants and moderate food test date 10/10/2017, test time unknown due to thermal tape being illegible (inhalants)/14:46 (food) Patient #171005007: collection date 09/30/2017, collection time 12:00 pm, received date 10 /05/2017 (note received time was not documented), southeastern inhalants test date 10 /10/2017, test time unknown due to thermal tape being illegible Patient #171005009: collection date 10/03/2017, collection time 11:00, received date 10/05/2017 (note received time was not documented), southeastern inhalants test date 10/10/2017, test time unknown due to thermal tape being illegible 6. According to records the laboratory had an annual test volume of 42,000 allergy tests on the Hitachi analyzer. 7. During an interview on 12/18/19 at 1:55 pm, TP-1 stated that no studies were performed on specimens undergoing more than one freeze-thaw cycle. This confirmed the above findings. The laboratory did not follow manufacturer's instructions for correct storage of specimens upon receipt and for ensuring correct conditions during transport. The laboratory did not document disposition of specimens upon receipt to -- 10 of 61 -- ensure manufacturer's instructions were met. III. Based on review of direct observation, laboratory's policy, manufacturer's instructions, test requisitions, and confirmed in interview, the laboratory failed to establish a policy for the rejection of hemolyzed specimens used in allergy testing. Findings: 1. Review of Hitachi CLA-1 allergy analyzer manufacturer's instructions "4 Test Operation" page 4-2 stated: "Collect a venous blood sample Hemolysis can adversely affect the performance of the CLA Allergy Assay." 2. Review of "PATIENT TEST MANAGEMENT- SPECIMEN ACCESSIONING AND PROCESSING" policy page 1 and 2 stated: "ACCESSIONING 5. Note on the request the number and type of specimens received and any comments peculiar to the specimen (e.g. specimen received frozen, hemolyzed)." The policy failed to define rejection criteria for hemolyzed specimens. 3. Review of the laboratory's client services manual "BLOOD COLLECTION FOR ALLERGY TESTING" page 5 stated: "COMMON CAUSES OF UNACCEPTABLE SERUM OR PLASMA SPECIMENS AND INNACCURATE TEST RESULTS: HEMOLYSIS Grossly or moderately hemolyzed specimens may be rejected and even slight hemolysis may alter certain test results." The client services manual failed to define rejection criteria for hemolyzed. 4. Review of a random sampling of test requisitions for 2017 and 2018 revealed on 06/06/2017 the laboratory received the following specimen: patient #17071008, a notation was made on the right top corner of the test requisition "Noted 6-6-17 (Initials)", "*Hemolyzed*", "6-12-17 (Initials) set up" Test records revealed the sample was analyzed on 06/14/2017. The laboratory failed to document notification to the client of hemolysis and how it can "adversely affect the performance of the CLA Allergy Assay" During an interview on 12/17/18 at 3:56 pm, Testing Person-1 (TP-1) was asked for a specimen rejection log and he stated that there was no log and they just call the clients to notify them what was done wrong. 5. During a closing interview on 12/19/18 at 12:32 pm, TP-1 and TP-2 confirmed the above mentioned patient specimen was tested and not rejected. 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: I. Based on review of Beckman Coulter AU 480 urine toxicology analyzer patient test records from 03/03/2017 through 12/12/2018, and confirmed in interview, the laboratory failed to document the time 67 of 67 patient specimens were received into the laboratory for processing and testing. 1. A random review of Beckman Coulter AU 480 urine toxicology analyzer patient test records from 03/03/2017 through 12/12 /2018 revealed the laboratory failed to document the time 67 of 67 patient specimens were received. The following is a random sample of patient specimens in which the receipt time was NOT documented: Date of Receipt: 03/03/2017 Patient Number: 170303001 Date of Receipt: 06/22/2017 Patient Number: 170711001 Date of Receipt: 06/20/2017 Patient Number: 170711002 Date of Receipt: 06/20/2017 Patient Number: 170711003 Date of Receipt: 06/19/2017 Patient Number: 170711004 Date of Receipt: 07/12/2017 Patient Number: 170712001 Date of Receipt: 04/25/2017 Patient Number: 170712004 Date of Receipt: 07/28/2017 Patient Number: 170728001 Date of Receipt: 10/18/2017 Patient Number: 171018002 Date of Receipt: 10/23/2017 Patient Number: 171023004 Date of Receipt: 11/16/2017 Patient Number: 171116001 Date of Receipt: 01/18/2018 Patient Number: 180118002 Date of Receipt: 03/27/2018 Patient Number: 180327001 Date of Receipt: 03/28/2018 Patient Number: 180328001 Date of Receipt: 04/02/2018 Patient Number: 180402001 Date of Receipt: 04/24/2018 Patient Number: -- 11 of 61 -- 180424001 Date of Receipt: 07/17/2018 Patient Number: 180717002 Date of Receipt: 07/19/2018 Patient Number: 180719002 Date of Receipt: 10/09/2018 Patient Number: 181009001 Date of Receipt: 10/09/2018 Patient Number: 181009002 Date of Receipt: 10/09/2018 Patient Number: 181009003 Date of Receipt: 10/09/2018 Patient Number: 181009004 Date of Receipt: 10/26/2018 Patient Number: 181026001 Date of Receipt: 10/26/2018 Patient Number: 181026002 Date of Receipt: 10/26/2018 Patient Number: 181026003 Date of Receipt: 12/12/2018 Patient Number: 181212001 Date of Receipt: 12/11/2018 Patient Number: 181211002 2. The above findings were confirmed in an interview with the laboratory staff on 12/19/2018 at 1022 hours in the conference room. 40420 II. Based on review of manufacturer's instructions, patient test requisitions, final test reports, and confirmed in interview, the laboratory failed to document the received time of specimens that were received from outside clients for 60 of 60 patients in 2017 (06/2017, 07/2017, 08/2017, 09/2017, 10/2017, 12/2017) and 10 of 10 patients 2018 (08/2018, 09/2018, 10/2018) for allergy testing. Findings: 1. Review of Hitachi analyzer manufacturer's instructions "4 Test Operation" page 4-3 stated: "Store Serum Store serum samples at 2-8 for a period of up to one week. For longer storage, samples should be frozen at -20C. Repeated freezing and thawing of serum samples should be avoided. Storage in a frost-free refrigerator may affect the long-term stability of the sample." 2. Review of patient test requisitions and final test reports, revealed that the received time was not documented on requisitions nor final test reports in 2017 and 2018 as follows: (this was a random sampling) Patient#170925004 collection date: 09/19/17, received date: 09/22/2017 Patient#170925003 collection date: 09/19/17, received date: 09/22/2017 Patient#170925002 collection date: 09/20/17, received date: 09/22/2017 Patient#170925001 collection date: 09/20/17, received date: 09/22/2017 Patient#170929004 collection date: 09/26/17, received date: 09/29/2017 Patient#170929002 collection date: 09/26/17, received date: 09/29/2017 Patient#170929003 collection date: 09/22/17, received date: 09/29/2017 Patient#171004001, no lab requisition available, collection date: 10/02/2017 (from final test report), received date: 10/04/2017 (from final test report) Patient#170914004 collection date: 09/12/17, received date: 09/14/2017 Patient#170914003 collection date: 09/12/17, received date: 09/14/2017 Patient#170914002 collection date: 09/11 /17, received date: 09/14/2017 Patient#170824004 collection date: 08/22/17, received date: 09/14/2017 Patient#170914005 collection date: blank, collection time blank, received date: 09/12/2017 Patient#170907001 collection date: 09/01/17, received date: 09/07/2017 Patient#170907003 collection date: 09/01/17, received date: 09/07 /2017 Patient#170075002 collection date: 09/01/17, received date: 09/07/2017 Patient#170710008 collection date: 06/01/17, received date: 06/06/2017 Patient#170608020 collection date: 06/01/17, received date: 06/01/2017 Patient#17068019 collection date: 06/01/17, received date: 06/01/2017 Patient#170608018 collection date: 06/01/17, received date: 06/01/2017 Patient#17060817 collection date: 06/01/17, received date: 06/01/2017 Patient#170608016 collection date: 06/01/17, received date: 06/01/2017 Patient#170608015 collection date: 06/01/17, received date: 06/01/2017 Patient#170608014 collection date: 06/01/17, received date: 06/01/2017 Patient#170608013 collection date: 06/01/17, received date: 06/01/2017 Patient#170608012 collection date: 06/01/17, received date: 06/01/2017 Patient#170710007 collection date: 06/08/17, received date: 06/08/2017 Patient#170608022 collection date: 06/08/17, received date: 06/08/2017 Patient#170608021 collection date: 06/08/17, received date: 06/08/2017 Patient#170608023 collection date: 06/08/17, received date: 06/08/2017 Patient#170608024 collection date: 06/08/17, received date: 06/08/2017 Patient#170710011 collection date: 06/07/17, received date: 06/09/2017 -- 12 of 61 -- Patient#170710010 collection date: 06/08/17, received date: 06/09/2017 Patient#170710009 collection date: 06/06/17, received date: 06/09/2017 Patient#170710013 collection date: 06/05/17, received date: 06/07/2017 Patient#170726007 collection date: 07/24/17, received date: 07/26/2017 Patient#170726008 collection date: 07/21/17, received date: 07/26/2017 Patient#170726009 collection date: 07/19/17, received date: 07/26/2017 Patient#170726011 collection date: 07/21/17, received date: 07/26/2017 Patient#170801008 collection date: 07/29/17, received date: 08/01/2017 Patient#170728002 collection date: 07/25/17, received date: 07/28/2017 Patient#170816007 collection date: 08/12/17, received date: 08/12/2017 Patient#170816006 collection date: 08/12/17, received date: 08/12/2017 Patient#170824006 collection date: 08/22/17, received date: 08/24/2017 Patient#170824005 collection date: 08/22/17, received date: 08/24/2017 Patient#170831004 collection date: 08/29/17, received date: 08/31/2017 Patient#170831003 collection date: 08/26/17, received date: 08/31/2017 Patient#170831002 collection date: 08/26/17, received date: 08/31/2017 Patient#170831001 collection date: 08/26/17, received date: 08/31/2017 Patient#171005005 collection date: 10/05/17, received date: 10/05/2017 Patient#171005006 collection date: 10/05/17, received date: 10/05/2017 Patient#171005007 collection date: 09/30/17, received date: 10/05/2017 Patient#171005008 collection date: 09/30/17, received date: 10/05/2017 Patient#171005009 collection date: 10/03/17, received date: 10/05/2017 Patient#171213004 collection date: 12/12/17, received date: 12/13/2017 Patient#171213005 collection date: 12/12/17, received date: 12/13/2017 Patient#171213006 collection date: 12/12/17, received date: 12/13/2017 Patient#171213001 collection date: 12/12/17, received date: 12/13/2017 Patient#171213002 collection date: 12/12/17, received date: 12/13/2017 Patient#171213003 collection date: 12/12/17, received date: 12/13/2017 Patient#180904010 collection date: 08/30/18, received date: 09/04/2018 Patient#180913007 collection date: blank (final report 09/10/18), collection time: blank, received date: 09/13/2018 Patient#180917001 collection date: 09/13/18, received date: not stamped on requisition (final report 09/17/2018) Patient#181008007 collection date: blank (final report 09/18/18), collection time: blank, received date: 10/08/2018 Patient#181008006 collection date: blank (final report 09/17/18), collection time: blank, received date: 10/08/2018 Patient#181008005 collection date: 09/24/18, received date: 10/08/2018 Patient#181008001 collection date: blank (final report 09/26/18), collection time: blank, received date: 10/08/2018 Patient#181008002 collection date: blank (final report 09/26/18), collection time: blank, received date: 10/08/2018 Patient#181008003 collection date: blank (final report 09/20/18), collection time: blank, received date: 10/08/2018 Patient#181008004 collection date: 09/24/18, received date: 10/08/2018 The laboratory had an annual test volume of 42,000 allergy tests on the Hitachi CLA-1 analyzer. 3. During an interview on 12/19/2018 at 10:30 am, Testing Person-1 (TP-1) and Testing Person-2 (TP-2) confirmed that received time of specimens was not documented. TP-1 stated that the computer system did not allow them to document the received time. This confirmed the above findings. 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. -- 13 of 61 -- This STANDARD is not met as evidenced by: I. Based on review of Thermo Scientific DRI urine assay manufacturer's instructions, laboratory's documents, and staff interview, the laboratory failed to ensure all components for proper handling of urine specimens were included in their client services document. Findings included: 1. Review of the Thermo Scientific DRI urine drug assay manufacturer's instructions for urine toxicology analytes specified the following in the section titled "Specimen Collection and Handling": a. Amphetamines (0138-12-EN 2017 08) "Collect urine specimens in plastic or glass containers. C