American Medical Center Laboratory

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director (LD), the laboratory failed to follow established written policies and procedures for its laboratory testing for 5 (July 2022 to February 2023) of 5 months of testing. Findings include: 1. A record review of the "Policies and Procedure" manual revealed for 5 (July 2022 to February 2023) of 5 months of testing the laboratory did not follow the "Laboratory General Maintenance" policy and procedures or the procedure was lacking current methods and technologies as follows: a. Documenting and recording of temperatures. b. General maintenance on the centrifuge. c. Thermometer calibration. d. Pipette calibration Validation not up to date. e. No procedure for specimen collection, handling, and processing of urine toxicology specimens. f. No policy or procedure for the temperature recording for the Corning LSE heating block. 2. An interview on 2/27/2023 at 11:53 am, the LD confirmed the "Policies and Procedure" manual was not followed and not current and up to date. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: . Based on observation, lack of documentation, and interview with the Laboratory Director (LD), the laboratory failed to perform and document the thermometer calibration checks as required by the manufacturer before the expiration for 3 (traceable thermometers) of 3 thermometers in use in the laboratory. Findings include: 1. During a tour of the laboratory on 2/27/2023 at 9:20 am, the surveyor observed 3 of 3 thermometers in use past their expiration date of 9/28/2020 as follows: a. Whirlpool refrigerator S/N 181625068. b. Whirlpool freezer S/N 181625066. c. Kenmore refrigerator S/N 181625052. 2. A record reviewed revealed a lack of documentation for the calibration of the 3 thermometers and/or replacement by the expiration of 9/28 /2020. 3. A interview on 2/27/2023 at 9:22 am, the LD confirmed the 3 thermometers were not calibrated and/or replaced before their expiration. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on observation, lack of documentation, and interview with the Laboratory Director (LD) and the Testing Personnel (TP), the laboratory failed to perform and document the temperature recordings for the Corning LSE heating block on days of use for 8 (July 2022 to February 2023) of 8 months in use. Findings include: 1. During a tour of the laboratory on 2/27/2023 at 9:20 am, the surveyor observed a Corning LSE heating block on the tabletop with a thermometer in one of the testing wells. 2. A record review on 2/27/2023 at 11:53 am revealed a lack of documentation for the temperature of the heating block on the days of testing. 3. When queried on 2/27/2023 at 11:53 am, TP stated that the temperature is looked at but not recorded. 4. A interview on 2/27/2023 at 11:53 am, the LD and TP confirmed the heating block temperature was not recorded on the days on the testing. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director (LD), the laboratory failed to provide the correct name and address of the laboratory performing -- 2 of 3 -- the highly complex toxicology testing on its test reports for 6 (A2, D4, H3, M9, R3, and V9) of 6 patient test reports reviewed. Findings include: 1. A review of the laboratory's patient test reports revealed the name and address of the laboratory performing the toxicology testing was not the same as what is written on the CMS- 116 application or what's in the CMS database for the following test results: a. Run A patient 2 - MG604647. b. Run D patient 4 - BS371785. c. Run H patient 3 - JA877477. d. Run M patient 9 - ND28966. e. Run R patient 3 - GO795353. f. Run V patient 9 - LP3372. 2. An interview on 2/27/2023 at 1:15 pm, the LD confirmed the name and address on the patient's final reports was not the correct. ***Repeat Deficiency from the 9/19/2018 survey*** -- 3 of 3 --

Summary Statement of Deficiencies D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on the number and severity of the deficiencies cited herein, the Condition: Toxicology was not met. Findings include: 1. The laboratory failed to verify the accuracy of toxicology analytes at least twice annually. Refer to D5217. 2. The laboratory failed to ensure reagents used in toxicology testing did not exceed their expiration date. Refer to D5417. 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 the Laboratory Director (LD), the laboratory failed to verify the accuracy of toxicology analytes at least twice annually for 2 (November 2018 to November 2020) of 2 years reviewed. Findings include: 1. A review of the laboratory's test menu revealed it tests urine and oral specimens for the following analytes: a. 6-MAM b. 7-amino clonazepam c. Alpha-hydoxyalprazolam d. Alprazolam e. Amitriptyline f. Amphetamine g. Benzoylecgonine h. Buprenorphine i. Carisoprodol j. Cotinine k. Codeine l. Cyclobensaprine m. Desipramine n. Desmethyl- tapentadol o. Doxepin p. 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- q. Fentanyl r. Flunitrazepam s. Flurazepam t. Gabapentin u. Hydrocodone v. Hydromorphone w. Imipramine x. Ketamine y. Lorazepam z. 3,4- Methylenedioxyamphetamine (MDA) aa. 3,4-Methylenedioxy-N-ethylamphetamine Drug (MDEA) bb. 3,4-Methylenedioxymethamphetamine (MDMA) cc. Merperidine dd. Meprobamate ee. Methadone ff. Methamphetamine gg. Methylphenidate hh. Midazolam ii. Morphine jj. Naloxone kk. Naltrexone ll. Norbuprenorphrine mm. Nordiazepam nn. Norfentanyl oo. Norhydrocodone pp. Norketamine qq. Noroxymorphone rr. Nortriptyline ss. Oxazepam tt. Oxycodone uu. Oxymorphone vv. Phenylcyclohexyl piperidine (PCP) ww. Pregabalin xx. Propoxephene yy. Ritilinic Acid zz. Sertraline aaa. Tapentadol bbb. Temazpam ccc. Tramadol ddd. Zolpidem eee. Tetrahydrocannabinol (THC) fff. Amobarbital Pentobarbital ggg. Butabarbital hhh. Butalbital 2. A review of the laboratory's "Comparison Test" data revealed a lack of documentation for twice annual verification of accuracy testing for the following analytes not covered by the College of American Pathologists' proficiency testing events in 2019 and 2020: a. Amitriptyline b. Cotinine c. Desipramine d. Doxepin e. Imipramine f. Ketamine g. Methylphenidate h. Midazolam i. Naloxone j. Naltrexone k. Norketamine l. Nortriptyline m. Nortriptyline n. Zolpidem o. Amobarbital Pentobarbital p. Butabarbital 3. A review of the laboratory's College of American Pathologists' proficiency testing records revealed a lack of enrollment for 2019, resulting in the lack of twice annual verification of accuracy for the following analytes in 2019 not covered under the laboratory's "Comparison Test" data: a. Carisoprodol b. Meprobamate c. Norhydrocodone d. Noroxymorphone e. Propoxephene f. Temazpam g. Butalbital 4. An interview on 11/23/20 at 10:30 am with the LD confirmed the laboratory did not verify the accuracy of all of its toxicology analytes at least twice annually. ***This is a repeated deficiency from the 9/19/18 recertification survey*** D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with Testing Personnel #1 (TP1), the laboratory failed to ensure reagents used in toxicology testing did not exceed their expiration date for 312 patients tested since the expiration date elapsed. Findings include: 1. The surveyor observed a bottle of Methanol with the expiration date of 7/22 /2020. 2. An interview with TP1 on 11/23/20 at 9:14 am revealed the laboratory had not received a new lot of Methanol since they started working at the facility in June 2019 and the contents of the expired bottle were used in reagent preparation. 3. A review of the laboratory's "Drugs in Urine 4500 LCMSMS" procedure revealed Methanol is used in preparing the Mobile Phase B reagent used in toxicology testing. 4. A review of the laboratory's "Test Reagents" procedure revealed a section stating, "No material will routinely be used that is out-of-date." 5. An interview with TP1 on 11/23/20 at 12:17 am revealed 312 patients had been tested since the Methanol had expired. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. -- 2 of 6 -- 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 record review and interview, the laboratory director failed to provide overall management and direction. Findings include: 1. The Laboratory Director failed to ensure quality assessment programs were maintained. Refer to D6094. 2. The Laboratory Director failed to ensure testing personnel were trained to perform toxicology testing prior to reporting patient test results. Refer to D6101. 3. The Laboratory Director failed to ensure testing personnel were competent to perform toxicology testing. Refer to D6103. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director (LD), the Laboratory Director failed to ensure quality assessment programs were maintained for 2 (November 2018 to November 2020) of 2 years. Findings include: 1. A review of the laboratory's "Laboratory Quality Assessment Plan" procedure revealed a section stating, "The Comprehensive Quality Assessment Program (QA) is structured to monitor and evaluate the ongoing and overall quality of all aspects of the testing process (Pre-analytic, Analytic, and Post-analytic)." 2. A review of the laboratory's records revealed a table of contents stating, "6. Quality Assessment Documentation Folder Quality Assurance Goal. 6.1 Monthly Meeting". Documentation of quality assessments was not available. 3. The surveyor requested the laboratory's quality assessment documentation from November 2018 to November 2020 on 11/23/20 at 9: 57 am and it was not made available. 4. An interview on 11/23/20 at 9:57 am with the LD revealed the laboratory has not performed ongoing quality assessments for its high complexity toxicology testing. D6101 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(11) The laboratory director must employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart. This STANDARD is not met as evidenced by: . Based on observation, record review, and interviews, the Laboratory Director failed to ensure testing personnel were trained to perform toxicology testing prior to reporting patient test results for 2 (Testing Personnel #1 and Office Personnel #1) of 2 personnel employed by the laboratory. Findings include: 1. An interview with the Laboratory Director (LD) on 11/23/20 at 9:23 am revealed Testing Personnel #1 started employment with the laboratory on 6/3/2019. 2. An interview with Office -- 3 of 6 -- Personnel #1 on 11/23/20 at 11:42 am revealed he has been performing toxicology testing. 3. A review of the laboratory's personnel records revealed a lack of documentation of training in toxicology testing for Testing Personnel #1 and Office Personnel #1. 4. An interview on 11/23/20 at 12:17 pm with the LD confirmed testing personnel did not have documented training or competency assessments. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: . Based on observation, record review, and interviews, the Laboratory Director failed to ensure testing personnel were competent to perform toxicology testing for 2 (Testing Personnel #1 and Office Personnel #1) of 2 personnel employed by the laboratory. Findings include: 1. An interview with the Laboratory Director (LD) on 11 /23/20 at 9:23 am revealed Testing Personnel #1 started employment with the laboratory on 6/3/2019. 2. An interview with Office Personnel #1 on 11/23/20 at 11: 42 am revealed he has been performing toxicology testing. 3. A review of the laboratory's "Testing Personnel- Performance Evaluation Competency Assessment" procedure revealed a section stating, "The required competencies for this position are as per the attached initial and periodic competency review." 4. A review of the laboratory's "Overall Competency Testing Program Assessment" procedure revealed a section stating, "To ensure that individuals responsible for laboratory testing maintain competency in order to perform test procedures and analysis accurately, proficiently, and according to the specified policy and procedure." 5. A review of the laboratory's personnel records revealed a lack of competency assessment documentation for Testing Personnel #1 and Office Personnel #1. 5. An interview on 11/23/20 at 12:17 pm with the LD confirmed testing personnel did not have documented competency assessments. D6134 CLINICAL CONSULTANT CFR(s): 493.1453 The laboratory must have a clinical consultant who meets the requirements of 493. 1455 of this subpart and provides clinical consultation in accordance with 493.1457 of this subpart. This CONDITION is not met as evidenced by: . Based on record review and interview with the Laboratory Director, the laboratory failed to ensure the Clinical Consultant met the qualification requirements at 493.1457 of this part. Findings include: 1. The laboratory failed to employ a qualified Clinical Consultant. Refer to D6135. D6135 CLINICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1455 -- 4 of 6 -- The clinical consultant must be qualified to consult with and render opinions to the laboratory's clients concerning the diagnosis, treatment and management of patient care. The clinical consultant must-- (a) Be qualified as a laboratory director under 493. 1443(b)(1), (2), or (3)(i) or, for the subspecialty of oral pathology, 493.1443(b)(6); or (b) Be a doctor of medicine, doctor of osteopathy, doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director, the laboratory failed to employ a qualified Clinical Consultant for 2 (November 2018 to November 2020) of 2 years. Findings include: 1. A review of the CMS-209 form revealed the Laboratory Director was also listed as the Clinical Consultant. 2. A review of the Laboratory Director's qualifications revealed the following: a. He did not qualify as a laboratory director under 493.1443(b)(1), (2), or (3)(i). b. He is not a doctor of medicine, doctor of osteopathy, doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located. 3. An interview on 11/24/20 at 11:50 am with the Laboratory Director confirmed he did not meet the qualifications to serve as the Clinical Consultant. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: . Based on document review and interviews, the laboratory failed to ensure personnel performing high complexity toxicology testing met the qualification requirements at 42 CFR 493.1489 for 1 (Office Personnel #1) of 2 testing personnel. Findings include: 1. The laboratory failed to ensure testing personnel was qualified to perform high complexity toxicology testing. See D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or -- 5 of 6 -- medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: . Based on record review and interviews, the laboratory failed to ensure testing personnel was qualified to perform high complexity toxicology testing for 1 (Office Personnel #1) of 2 testing personnel. Findings include: 1. An interview on 11/23/20 at 11:42 am with Office Personnel #1 revealed he has been performing toxicology testing at the laboratory. 2. A review of the laboratory's personnel records revealed a lack of qualification documentation for Office Personnel #1. 3. An interview on 11/23 /20 at 12:17 pm with the Laboratory Director revealed Office Personnel #1 was not qualified to be performing high complexity testing. -- 6 of 6 --

Summary Statement of Deficiencies 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 test requisition review and interview, the requesting laboratory failed to provide the required information to the testing facility for one (#1) of ten patient charts audited. Findings include: 1. On December 10, 2018 at 12:15 PM, test requisition review revealed the ordering physician, date of birth, source of the specimen, date of collection, and the tests to be performed were not included on the ordering requisition. 2. On December 10, 2018 at 12:15 PM when queried, testing personnel #1 as listed on the CMS-209 stated the "specimen had at least two identifiers" in which to run the specimen. 3. During the interview on December 10, 2018 at 12:30 PM, the laboratory director as listed on the CMS-209 confirmed the testing personnel did not follow protocol on specimen acceptability. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on record review and interview, the laboratory failed to meet the requirements for the specialty in Toxicology as specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. Findings include: 1. The laboratory failed to verify the accuracy of the urine toxicology specific gravity testing. Refer to D5217. 2. The laboratory failed to have a written and/or electronic request for patient testing. Refer to D5301. 3. The laboratory failed to enter test requisitions accurately. Refer to D5309. 4. The laboratory failed to perform and document refrigerator/freezer and humidity thermometer calibrations, timer checks, and centrifuge rotations per minute (RPM) checks. Refer to D5429. 5. The laboratory failed to perform the routine chemistry and toxicology daily quality control. Refer to D5445. 6. The laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems in the laboratory analytic systems. Refer to D5791. 7. The laboratory failed to identify the name and address of the facility performing the primary and secondary toxicology testing. Refer to D5805. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to verify the accuracy at least twice annually for the urine toxicology specific gravity testing on the BS-480 Mindray chemistry analyzer for one (2018) of two years of testing. Findings include: 1. On September 19, 2019 at 11:54 AM, verification of accuracy record review for the urine toxicology specific gravity testing revealed there was no documentation to show the testing was completed at least twice annually in 2018. 2. During the interview on September 19, 2018 at 11:54 AM, the laboratory director as listed on the CMS-209 confirmed the testing was not completed. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to have a written and/or electronic request for patient testing from an authorized person for the toxicology "Comprehensive Drug Analysis" testing for one ( #1) of eight patient charts audited. Findings include: 1. On September 19, 2018 at approximately 2:30 PM, record review revealed for one (#1) of eight patient charts audited, the laboratory did not have a written and/or electronic request for the toxicology testing. 2. During the interview on September 19, 2018 at approximately 4:00 PM, the office staff personnel confirmed the laboratory did not have a written and/or electronic request for the laboratory testing performed. D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to order tests correctly for seven (#2-#8) of eight patient requisitions audited. Findings include: 1. On September 19, 2018 at approximately 4:00 PM, record review for seven (#2 #8) of nine patient test requisitions and final reports from June 5, 2018 to September 10, 2018 revealed the following discrepancies: Patient #2 a. The electronic requisition revealed an order for a urine "Comprehensive Drug Analysis" panel. b. The electronic order submitted by the physician on March 3, 2018 included the following tests that were not on the final report: Zaleplon and THC-OH. Patient #3 a. The electronic requisition revealed an order for a urine "Comprehensive Drug Analysis" panel. b. The electronic order submitted by the physician on May 30, 2018 included the following tests that were not on the final report: Zaleplon and THC-OH. Patient #4 a. The electronic requisition revealed an order for a urine "Comprehensive Drug Analysis" panel. b. The electronic order submitted by the physician on July 11, 2018 included the following tests that were not on the final report: Zaleplon and THC-OH. Patient #5 a. The electronic requisition revealed an order for a urine "Primary Testing Only". b. The electronic order submitted by the physician on July 19, 2018 did not -- 2 of 5 -- include a "Comprehensive Drug Analysis" panel that included the following tests that were not ordered: Amphetamine, Methamphetamine, Amobarbital Pentobarbital, Butabarbital, Butalbital, Phenobarbital, Alprazolam, Clonazepam, 7-Amino Clonazepam, Flunitrazepam, Flurazepam, Hydroxyalprazolam, Lorazepam, Midazolam, Nordiazepam, Oxazepam, Temazepam, Codeine, Norhydrocodone, Hydrocodone, Hydromorphone, Morphine, MDA, MDEA, MDMA, Meperidine, Naloxone, Naltrexone, Zolpidem, Zaleplon, Cyclobenzaprine, Carissoprodol, Meprobamate, Sertaline, Amitriptyline, Desipramine, Doxepin, Imipramine, Nortriptyline, Buprenorphine, Norbuprenorphine, THC-OH, THC-COOH, Benzoylecgonine, Fentanyl, Norfentanyl, Gabapentin, 6-MAM, Ketamine, Norketamine, EDDP, Methadone, PCP, Methylphenidate, Ritilinic Acid, Pregabaline, Oxycodone, Noroxycodone Oxymorphone, Propoxyphone, Tramadol, D- Desmethyltramadol and Cotinine. Patient #6 a. The electronic requisition revealed an order for a urine "Comprehensive Drug Analysis" panel. b. The electronic order submitted by the physician on August 1, 2018 included the following tests that were not on the final report: Zaleplon and THC-OH. Patient #7 a. The electronic requisition revealed an order for a "Oral" panel for oral fluid specimen. b. The electronic order submitted by the physician on August 1, 2018 included the following tests that were not on the final report: Clonazepam, 7-Amino Clonazepam, Norhydrocodone, Zaleplon, THC-OH, Norfentanyl, Norketamine, EDDP, Noroxymorphone, and D- Desmethyltramadol. Patient #8 a. The electronic requisition revealed an order for a "Oral" panel for oral fluid specimen. b. The electronic order submitted by the physician on August 15, 2018 included the following tests that were not on the final report: Clonazepam, 7-Amino Clonazepam, Norhydrocodone, Zaleplon, THC-OH, Norfentanyl, Norketamine, EDDP, Noroxymorphone, and D-Desmethyltramadol. 2. During the interview on September 19, 2018 at approximately 4:00 PM, the laboratory director as listed on the CMS-209 was informed that discrepancies were noted on the final reports. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on observation, lack of records, and interview, the laboratory failed to perform and document refrigerator/freezer and humidity thermometer calibrations, timer checks, and centrifuge rotations per minute (RPM) checks for two (September 2016 - September 2018) of two years. Findings include: 1. During a tour of the laboratory on September 19, 2018 at 8:50 AM, the surveyor observed "Fisher Scientific" thermometers in the Whirlpool refrigerator and freezer with a calibration due date of 11/14/14 and a "Control Company" hygrometer/room temperature thermometer on the desk next to the AbSciex Triple Quad 4500MD LC/MS analyzer with no calibration due date or put into use date. 2. On September 19, 2018 at approximately 10:04 AM, the laboratory did not have available to the surveyor records to show the thermometers had been calibrated, timer and centrifuge checks performed and documented for two (September 2016 - September 2018) of two years of operation. 3. On September 19, 2018 at approximately 10:04 AM, the laboratory director as listed on the CMS-209 confirmed the thermometer calibrations, timer and centrifuge checks had not been performed and documented. -- 3 of 5 -- D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to perform the routine chemistry and toxicology quality control each day of patient testing for two ( June 5 and June 15, 2018) of nine days of patient testing audited on the day of the survey. Findings include: 1. On September 19, 2018 at approximately 2:28 PM, record review for two (June 5 and 15, 2018) of nine days of patient testing audited, there was no documentation of two levels of quality control performed and documented prior to testing patient samples as follows: a. June 5, 2018 - 60 patients tested b. June 15, 2018 - 89 patients tested 2. During the interview on September 19, 2018 at approximately 2: 28 PM, testing personnel #1 as listed on the CMS-209 confirmed quality control was not performed and documented prior to testing patient samples. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems as specified in 493.1251 through 493.1283 in the analytic laboratory systems for seven (March -September 2018) of 12 months reviewed. Findings include: 1. On September 19, 2018 at 12:42 PM, record review of the monthly quality assurance forms revealed the laboratory did not have documentation to show the analytic systems were being monitored for seven (March - September 2018) of 12 months reviewed. 2. During the interview on September 19, 2018 at 12:42 PM, the laboratory director as listed on the CMS-209 confirmed there was no quality assurance documentation in 2018. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units -- 4 of 5 -- of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to identify the name and address of the facility performing the secondary toxicology testing for eight (#1 - #8) of eight patient charts audited. Findings include: 1. On September 19, 2018 at approximately 3:30 PM, record review of the final patient results for eight ( #1 - #8) of eight charts audited revealed the name and address of the testing facility was not included on the final report. 2. During the interview on September 19, 2018 at approximately 3:30 PM the laboratory director as listed on the CMS-209 confirmed the final reports did not include the name and address of the testing facility. -- 5 of 5 --