Dallas Co Dept Of Health & Human Services

Summary Statement of Deficiencies D0000 An onsite recertification survey conducted August 5-7, 2024, found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on surveyor observation, review of manufacturer's instructions, laboratory environmental records, and confirmed in an interview with laboratory personnel, the laboratory failed to establish an acceptable room temperature range for six of six months reviewed in 2023 and 2024. The findings included: 1. Surveyor observation on August 5, 2024, in the STAT Lab (Room #111) found less than one liter of Reagent Alcohol stored in the flammable cabinet. Lot # 215263 Expiration date: 02- 2025 2. Review of the manufacturer's instructions on the outside packaging stated, "Store at 20-30 degrees Celsius". 3. Review of the laboratory's environmental records for the STAT Lab (Room #111) from May, June, July of 2024 and October, November, and December of 2023 found the laboratory established its room temperature range as follows: High Alarm Limit: 30.0 degrees Celsius Low Alarm Limit: 15.0 degrees Celsius 4. The laboratory failed to established an acceptable room temperature range per the manufacturer's instructions for the Reagent Alcohol. 5. In an interview at 10:43 hours on 08/05/2024, technical supervisor 4 (as listed on CMS From 209) confirmed the laboratory's range was too wide. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation, review of manufacturer's instructions, and confirmed in an interview with laboratory personnel, the laboratory failed to follow the manufacturer's instructions to monitor revised expiration dates for one of one box of Blood Bank Saline in use. The findings included: 1. Surveyor observation on August 5, 2024, in the STAT Lab (Room #111) found one box of 0.9% Blood Bank Saline in use. The box did not have an open date or a revised expiration date. Lot # 720284 Expiration date: 05/31/2024 2. Review of the manufacturer's instructions on the outside packaging stated, "Use within 30 days of open date". 3. The laboratory failed to document the open date or revised expiration date in order to ensure the saline was discarded within 30 days of the open date. 4. In an interview at 10:35 hours on 08/05 /2024, testing personnel #8 (as listed on CMS From 209) confirmed that the neither the revised expiration date or open date was documented. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An entrance conference was held with the laboratory representatives. The survey process was discussed, and survey forms were provided. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The laboratory representatives were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be NOT in compliance with the CLIA conditions for specialties /subspecialties surveyed for 42 CFR 493.1240 Pre-Analytic Systems Note: The CMS- 2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Centers for Medicare and Medicaid Services) national database and verified with the proficiency testing company, College of American Pathologists (CAP). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 Successful participation in a proficiency testing program 493.1441 Laboratory Director, (high complexity) D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a review of proficiency testing records from 2020 (1st, 2nd, and 3rd Events) and 2021 (1st and 2nd Events), it was revealed that the laboratory failed to attain an overall testing event score of at least 80% for the 3rd event of 2020 and 2nd testing event of 2021 for Bacteriology resulting in unsuccessful performance. Findings included: 1. Review of the CMS 0155 report revealed the following results: CAP 2020 - 3rd Event (D3-C 2020) laboratory received an overall unsatisfactory score 66% for Bacteriology. CAP 2021 - 2nd Event (D3-B 2021) laboratory received an overall unsatisfactory score 43% for Bacteriology 2. Review of the laboratory's CAP proficiency testing records revealed the following results: CAP 2020 - 3rd Event (D3- C 2020) laboratory received an overall unsatisfactory score 66% for Bacteriology. CAP 2021 - 2nd Event (D3-B 2021) laboratory received an overall unsatisfactory score 43% for Bacteriology. D2028 BACTERIOLOGY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records from 2020 (1st, 2nd and 3rd Events) and 2021 (1st and 2nd Events), it was revealed that the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Bacteriology. Two out of three consecutive unsatisfactory scores result in unsuccessful PT performance. Findings included: 1. Review of the CMS 0155 report revealed the following results: CAP 2020 - 3rd Event (D3-C 2020) laboratory received an overall unsatisfactory score 66% for Bacteriology. CAP 2021 - 2nd Event (D3-B 2021) laboratory received an overall unsatisfactory score 43% for Bacteriology 2. Review of the laboratory's CAP proficiency testing records revealed the following results: CAP 2020 - 3rd Event (D3-C 2020) laboratory received an overall unsatisfactory score 66% for Bacteriology. CAP 2021 - 2nd Event (D3-B 2021) laboratory received an overall unsatisfactory score 43% for Bacteriology. 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 a desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6089 D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2028. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An entrance conference was held with the laboratory representatives. The survey process was discussed and survey forms were provided. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The laboratory representatives were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in COMPLIANCE with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 An entrance conference was held on 01/22/19 with the general laboratory supervisor, QA/QC coordinator, LRN principle investigator, and laboratory section supervisor. The survey process was discussed. An opportunity for questions and comments was given. Based upon the onsite survey conducted 01/22/19 through 01/25/19, this facility was found NOT to be compliance with CLIA regulations found at 42 CFR for the specialties/subspecialties in which it was surveyed. 493.1240 Preanalytic Systems 493.1250 Analytic Systems 493.1403 Laboratory Director Moderate Complexity 493.1409 Technical Consultant 493.1441 Laboratory Director High Complexity 493.1447 Technical Supervisor An exit conference was held on 01/25/19 with the general laboratory supervisor, QA/QC coordinator, LRN principle investigator, laboratory director, and laboratory section supervisor. The exit conference attendees were advised the laboratory was out of compliance and advised of conditions and deficiencies found during the survey. An opportunity for questions and comments was provided. D3003 FACILITIES CFR(s): 493.1101(a)(2) The laboratory must be constructed, arranged, and maintained to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: Based on direct observation and interview, the laboratory failed to ensure minimal contamination of patient specimens with the HIV-1 NAAT testing as evidenced by: A. In direct observation of testing personnel #16 on 1-25-2019 @ 1015, the testing person for NAAT testing put following specimen tubes in a white refrigerator next to the testing area without adding new caps on the tubes to minimize contamination: Test date 1/25/2019 a. HIV002210 to HIV002216 (1 vacutainer tube) b. HIV001780 (f) (1 vacutainer tube) c. HIV002218 to 002227 (9 vacutainer tubes) d. HIV002284 (1 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 53 -- vacutainer tubes) e. HIV002285 (1 vacutainer tubes) f. HIV88 (1 vacutainer tubes) g. HIV002293 to 002311 (18 vacutainer tubes) h. HIV002312 toHIV002331 (20 vacutainer tubes) i. HIV002332 to HIV002351 (20 vacutainer tubes) B. In interview with testing personnel #16 @1010 she stated that after they pool the specimens of 20 for testing if one is tested positive they will retest the specimens to try and find out which one is positive for HIV by testing the samples again. c. The laboratory performs 73,500 HIV NAAT tests per year. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, personnel records, and staff interview, it was revealed the laboratory failed to have procedure used to perform or documentation of a competency assessment of the 4 of 4 general supervisors (GS-1, GS-2, GS-3, GS-4). Findings: 1. A review of the laboratory's policies revealed the laboratory failed to have a policy of when and how a competency assessment was to be performed on the general supervisor. 2. Review of personnel records for GS-1 revealed the last documented annual competency assessment was performed on 01/15 /2015. Review of personnel records for GS-2 revealed the last documented annual competency assessment was performed on 07/25/2015. The competency assessment was performed for the title of "Microbiologist" and not as one for a general supervisor. Review of personnel files for GS-3 revealed a hire date of 09/05/2017 and an initial training for Influenza on 01/2018. There was no documentation of semiannual performance for influenza (due 07/2018). Note there was no other documentation of initial training for other select agent testing (Bacillus, Brucella, Tularesnis, Pestis, Psuedomallei, Zika). Review of personnel records for GS-4 revealed there were no documented annual competency assessments since the employee was hired in April 2009. 3. During an interview on 01/23/2019 at 10:30 am, the laboratory director stated that he was aware that he failed to evaluate and document the annual performances of the general supervisors. He stated that he did not always have time to perform the annual assessments. This confirmed the above findings. 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 review of the laboratory's testing records, laboratory's procedures, and interview, the laboratory failed to have a procedure in place and to twice annually verify the accuracy of anal and nasopharyneal swabs for gonorrhea and chlamydia testing in 2018 as evidenced by: 1. The laboratory couldn't produce documentation to show that they have twice annually verified the accuracy of anal and nasopharyneal swabs in 2018. The laboratory was not enrolled in proficiency testing (PT) for these -- 2 of 53 -- two specimen types in 2018. 2. In review of the laboratory's procedures, the laboratory did not have procedure in place to verify twice annual accuracy of anal and nasopharyneal swabs. 3. In interview with the laboratory's QA manager on 1-24-2019 @1325, "We only do PT testing on what CAP sends us (urines only) We don't do twice a year accuracy of aptima anal/nasopharyneal swabs." 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 review of the laboratory's policy, patient test requisitions, manufacturer's instructions, patient test records, and laboratory's client service manual, the laboratory failed to meet the requirements of preanalytic systems, as evidenced by: 1. The laboratory failed to ensure patient test requisitions solicited the time of collection for wet mount specimens collected in the clinic and analyzed in the stat laboratory for 8 of 8 patients on 01/24/2019 (random sampling). Refer to D5305. 2. The laboratory failed to ensure urine Aptima gonorrhea (GC) and chlamydia (Chl) samples were within temperature specifications 2-30 degrees C for transport and receiving in the laboratory. Refer to D5311, I. 3. The laboratory failed to implement in their procedure a patient gram stain slide labeling policy. Refer to D5311, II. 4. The laboratory failed to ensure patient gram stain slides received into the stat laboratory for analysis were labeled with patient name or unique patient identifier for 7 of 7 patients on 01/23/2019 (random sampling). Refer to D5311, III. 5. The laboratory failed to define in their written policy the stability of wet mount specimens to ensure integrity of specimens when received and analyzed in the stat laboratory. Refer to D5311, IV. 6. The laboratory failed to make available the manual for their clients and have up to date information (specimen handling requirements) on what tests that laboratory performs. Refer to D5317. 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. -- 3 of 53 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's policy, patient test requisitions, and in interview with staff, the laboratory failed to ensure patient test requisitions solicited the time of collection for wet mount specimens collected in the clinic and analyzed in the stat laboratory for 8 of 8 patients on 01/24/2019 (random sampling). Findings included: 1. Review of "WET MOUNT PROCEDURE" did not include patient wet mount specimen stability or required documented information on patient test requisitions prior to analysis. Refer to D5311, IV. The wet mount specimens were collected by providers in the sexually transmitted disease (STD) clinic and walked over to the stat laboratory for microscopic analysis. 2. Review of patient "Order Requisition Report" for wet mount test (filled by collecting provider) and wet mount test result sheets (partially filled by collecting provider) from 01/24/2019 revealed the following: Patient #888400 order requisition report "Collection Date/Time:" was blank; test result sheet "Time Collected:" was blank. Patient #885961 order requisition report "Collection Date/Time:" was blank; test result sheet "Time Collected:" was blank. Patient #985061 order requisition report "Collection Date/Time:" was blank; test result sheet "Time Collected:" was blank. Patient #969376 order requisition report "Collection Date/Time:" was blank; test result sheet "Time Collected:" was blank. Patient #985062 order requisition report "Collection Date/Time:" was blank; test result sheet "Time Collected:" was blank. Patient #979193 order requisition report "Collection Date/Time:" was blank; test result sheet "Time Collected:" was blank. Patient #985068 order requisition report "Collection Date/Time:" was blank; test result sheet "Time Collected:" was blank. Patient #985066 order requisition report "Collection Date/Time:" was blank; test result sheet "Time Collected:" was blank. The laboratory did not ensure collection date/time were solicited on patient order requisition forms for patient testing. 3. During an interview on 01/24/2019 at 10:45 am, one of the providers of the STD clinic was asked about the blank collection date /time on patient order requisition forms and on the test result sheets, she stated the nurses should be stamping the date/time of collection when delivering to the stat laboratory for testing. The provider also pointed out on the order requisition form at the bottom where it says "Authorization-Please Sign and Date" is the name of the ordering provider and a date/time, she stated that is the collection date/time. The date /time by the provider's name did not indicate on the form whether this was the collection date/time. The "Collection Date/Time:" on the top right corner of the order requisition report for all patients was consistently blank. 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: Aptima Urine Samples: I. Based on direct observation, manufacturer's instructions, laboratory's policy, and interview, the laboratory failed to ensure urine Aptima gonorrhea (GC) and chlamydia (Chl) samples were within temperature specifications -- 4 of 53 -- 2-30 degrees C for transport and receiving in the laboratory as evidenced by: 1.In review of the manufacturer's instructions for the aptima GC and Chl states, " store processed urine specimens at 2 degrees C to 30 degrees C and assay within 30 days after transfer" 2. In direct observation on 1-24-2019 @0935 with the laboratory manager, aptima GC/Chl specimens from a nearby Texas county health department had specimens shipped via Fedex to the laboratory in a Styrofoam container with a ice pack on top of the specimens. The urine specimen were cold to the touch. The laboratory did not take any type of temperature reading to ensure that the specimens came into the laboratory within the 2-30 degrees C requirements. The following specimens were received from the nearby Texas county health department: CC 01960- 01978 date received 1-24-19 @0935. 3. In direct observation on 1-24-2019 @0945 with the laboratory manager, aptima GC/Chl specimen from a nearby jail had specimens carried from a courier with an ice pack on top of the specimens. The urine specimens were cold to the touch. The laboratory did not take any type of temperature reading to ensure the specimen came into the laboratory with the 2-30 degree C requirements. The following specimens were received from the nearby jail: JNC 01953-01959 date received 1-24-2019 @0930 4. In review of laboratory's policy for Aptima GC and Chl stated the same as the manufacturer's instructions "". It did not have a procedure for taking temperature on specimens. 5. In interview with the Laboratory manager 1-24-2019 @0948 he stated, "We don't take the temperature when we receive it in the lab, we don't have a temperature gun to take temperatures." 6. The laboratory performs 93,336 aptima combo Gc/Chl per year. 33867 II. Based on direct observation, laboratory's policy, patient test records, and in interview with staff, the laboratory failed to implement in their procedure a patient gram stain slide labeling policy. Findings included: 1. Review of the laboratory's policy for gram stain did not include patient gram stain slide labeling. The stat sexually transmitted disease (STD) clinic practice was providers collected a specimen from urethral, cervix, rectum, or throat. The specimen is collected by provider via swab and then smeared on a slide. The slide is then walked over to the stat lab for examination of gram negative diplococci (GND) (intracellular or extracellular). 2. During a tour of the stat laboratory on 01/24/2019 at 2:30 pm, there were 7 patient gram stain slides observed and only labeled with the patient's first name and last name initials and first initial of the provider who collected the specimen. The slides were analyzed for GND on 01/23 /2019. Review of patient test records (Daily N. gonorrhea Gram Stain Log-in) for the above slides observed were for Patient #985014, Patient #971447, Patient #973160, Patient #985021, Patient #985038, Patient #985045, Patient #961169, Patient #985017. The laboratory's procedure manual did not include labeling instructions for patient gram stain slides to ensure positive identification. 3. During an interview on 01 /24/2019 at 2:30 pm, Testing Person - 13 confirmed the above findings. During an interview on 01/24/2019 at 3:00 pm, the laboratory director was unable to provide a policy for labeling patient gram stain slides. III. Based on direct observation, laboratory's policy, patient test records, and in interview with staff, the laboratory failed to ensure patient gram stain slides received into the stat laboratory for analysis were labeled with patient name or unique patient identifier for 7 of 7 patients on 01/23 /2019 (random sampling). Findings included: 1. Review of the laboratory's policy for gram stain did not include patient gram stain slide labeling. The stat sexually transmitted disease (STD) clinic practice was providers collected a specimen from urethral, cervix, rectum, or throat. The specimen is collected by provider via swab and then smeared on a slide. The slide is then walked over to the stat lab for examination of gram negative diplococci (GND) (intracellular or extracellular). 2. During a tour of the stat laboratory on 01/24/2019 at 2:30 pm, there were 7 patient gram stain slides observed and only labeled with the patient's first name and last name initials and first initial of the provider who collected the specimen. The slides were analyzed for GND -- 5 of 53 -- on 01/23/2019. Review of patient test records (Daily N. gonorrhea Gram Stain Log- in) for the above slides observed were for Patient #985014, Patient #971447, Patient #973160, Patient #985021, Patient #985038, Patient #985045, Patient #961169, Patient #985017. The gram stain slides received into the laboratory did not include patient name or unique patient identifier. 3. During an interview on 01/24/2019 at 2: 30 pm, Testing Person - 13 confirmed the above findings. During an interview on 01 /24/2019 at 3:00 pm, the laboratory director was unable to provide a policy for labeling patient gram stain slides. IV. Based on review of the laboratory's policy, patient test requisitions, and in interview with staff, the laboratory failed to define in their written policy the stability of wet mount specimens to ensure integrity of specimens when received and analyzed in the stat laboratory. Findings included: 1. Review of "WET MOUNT PROCEDURE" did not include defined patient wet mount specimen stability or required documented information on patient test requisitions prior to analysis. The wet mount specimens were collected by providers in the sexually transmitted disease (STD) clinic and walked over to the stat laboratory for microscopic analysis. 2. Review of patient "Order Requisition Report" for wet mount test (filled by collecting provider) and wet mount test result sheets (partially filled by collecting provider) from 01/24/2019 revealed the following: Patient #888400 order requisition report "Collection Date/Time:" was blank; test result sheet "Time Collected:" was blank. Patient #885961 order requisition report "Collection Date /Time:" was blank; test result sheet "Time Collected:" was blank. Patient #985061 order requisition report "Collection Date/Time:" was blank; test result sheet "Time Collected:" was blank. Patient #969376 order requisition report "Collection Date /Time:" was blank; test result sheet "Time Collected:" was blank. Patient #985062 order requisition report "Collection Date/Time:" was blank; test result sheet "Time Collected:" was blank. Patient #979193 order requisition report "Collection Date /Time:" was blank; test result sheet "Time Collected:" was blank. Patient #985068 order requisition report "Collection Date/Time:" was blank; test result sheet "Time Collected:" was blank. Patient #985066 order requisition report "Collection Date /Time:" was blank; test result sheet "Time Collected:" was blank. The laboratory did not ensure collection date/time were solicited on patient order requisition forms for patient testing and did not have a defined stability of this specimen type. 3. According to laboratory records, the annual volume was 959 wet mount tests. 4. During an interview on 01/24/2019 at 10:45 am, Testing Person - 14 was asked what was the expected timeframe from time of collection to analysis for wet mount test, she stated, "5 minutes." The laboratory did not have a written policy defining the stability for wet mount specimens. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's client service manual, and interview, the laboratory failed to make available the manual for their clients and have up to date information (specimen handling requirements) on what tests that laboratory performs as evidenced by: 1. In interview with the Quality Assurance (QA) Manager on 1-23- 2019 @ 1425 stated he didn't think they had a client service manual, but later was able to find the documents on the computer. The document was written in 2016. In -- 6 of 53 -- questioning further after he found the manual, the QA manager stated that he didn't think that his clients served by the laboratory had the manual. He only sent out memos or talk with the laboratory's on the phone if they had questions concerning specimen collection. 2. In review of the laboratory's client service manual, the manual did not have the following new tests listed in it that have been added by the laboratory after 2016: Cepheid Xpert MTB-RIF Hologic Aptima HIV-1 RNA Kinyoun smear Quantiferon TB Biorad Bioplex Syphillis IgG/IgM Biorad Genius HIV 1/2 supplemental Biorad GS HIV combo ag/ab EIA Those new tests did not have following listed: patient preparation specimen collection requirements specimen labeling, specimen source specimen storage and preservation conditions for transport specimen acceptability and rejection 3. In the exit conference on 1-25-2019 with the Laboratory Director and his staff, he stated that he was aware that it was not updated and that in was created in 2016 to met regulatory requirements. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy, patient test requisitions, manufacturer's instructions, patient test records, and laboratory's client service manual, the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems, as evidenced by: 1. The laboratory failed to ensure patient test requisitions solicited the time of collection for wet mount specimens collected in the clinic and analyzed in the stat laboratory for 8 of 8 patients on 01/24/2019 (random sampling). Refer to D5305. 2. The laboratory failed to ensure urine Aptima gonorrhea (GC) and chlamydia (Chl) samples were within temperature specifications 2-30 degrees C for transport and receiving in the laboratory. Refer to D5311, I. 3. The laboratory failed to implement in their procedure a patient gram stain slide labeling policy. Refer to D5311, II. 4. The laboratory failed to ensure patient gram stain slides received into the stat laboratory for analysis were labeled with patient name or unique patient identifier for 7 of 7 patients on 01/23/2019 (random sampling). Refer to D5311, III. 5. The laboratory failed to define in their written policy the stability of wet mount specimens to ensure integrity of specimens when received and analyzed in the stat laboratory. Refer to D5311, IV. 6. The laboratory failed to make available the manual for their clients and have up to date information (specimen handling requirements) on what tests that laboratory performs. Refer to D5317. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. -- 7 of 53 -- This CONDITION is not met as evidenced by: Based on review of the laboratory's procedure, manufacturer's instructions for GenProbe Accuprobe Neisseria Gonorrhea Culture Identification Test, laboratory quality control/patient records, temperature logs, and maintenance records, the laboratory failed to meet the requirements of the analytic systems, as evidenced by: 1. The laboratory failed to have their staff follow their procedures with the HIV-1 NAAT testing. Refer to D5401, I. 2. The laboratory failed to ensure written policies were consistent with one another and with the laboratory's practice for changing gram stain reagents. Refer to D5401, II. 3. The laboratory failed to follow its own written policy to use a calibrated nephelometer to confirm the required McFarland standard for MGIT drug susceptibility testing. Refer to D5401, III. 4. The laboratory failed to follow its own written procedure and manufacturer's instructions for utilizing the correct ATCC organisms for quality control testing for the GenProbe Accuprobe Neisseria Gonorrhea Culture Identification Test. Refer to D5401, IV. 5. The laboratory failed to follow their own written policy to ensure that the specified ATCC organism was utilized for quality control testing. Refer to D5401, V. 6. The laboratory did not have procedures for the HIV-1 quantitative testing that started in December 2018. Refer to 5403, I. 7. The laboratory failed to implement written policies and procedures for preparing their own potassium hydroxide (KOH) and saline for wet mount tests. Refer to D5403, II. 8. The laboratory failed to implement QC procedures for reagin plasma reagin (RPR) card test and Biorad BioPlex 2200 analyzer. Refer to D5403, III. 9. The laboratory failed to follow manufacturer's instructions for the Aptima combo urine gonorrhea and chlamydia testing. Refer to D5411, I. 10. The laboratory failed to follow gram stain manufacturer's instructions for staining patient slides for 8 of 8 patients 01/23/2019 (random sampling). Refer to D5411, II. 11. The stat laboratory failed to follow manufacturer's instructions for using the correct saline in quantitative rapid plasma reagin (RPR) card test procedure for 166 days of 166 of QC and 69 of 69 patients from 05/2018 through 12/2018. Refer to D5411, III. 12. The main laboratory failed to follow manufacturer's instructions for using the correct saline in quantitative rapid plasma reagin (RPR) card test procedure for 102 of 102 days of QC from 06/2018 through 10/2018 and 01/2019 and 22 of 22 patients from 01 /2019 (random sampling of patients and QC). Refer to D5411, IV. 13. The laboratory failed to follow manufacturer's instructions for utilizing the correct ATCC organisms for quality control testing for the BD DrySlide Oxidase test. Refer to D5411, V. 14. The laboratory failed to monitor room temperature where aptima reagents are stored in the hallway. Refer to D5413, I. 15. The laboratory failed to monitor and document temperature of the stat laboratory in which reagents were stored. Refer to D5413, II. 16. The laboratory failed to monitor specimen collection tube storage and specimen blood collection temperature requirements for the Quantiferon TB Gold specimen collection tubes. Refer to D5413, III. 17. The laboratory failed to monitor room temperature as required for the Quantiferon TB Gold ELISA (Enzyme-linked immunosorbent assay) test. Refer to D5413, IV. 18. The laboratory failed to monitor the humidity for the BacTec MGIT 960 mycobacterial detection system. Refer to D5413, V. 19. The laboratory failed to define a temperature range for the phlebotomy room, in which collection supplies were stored, to ensure temperature did not exceed manufacturer instructions for 12 of 12 months in 2018. Refer to D5413, VI. 20. The laboratory failed to monitor and document temperature for the storage of BD blood collection tubes according to manufacturer's requirements for storage. Refer to D5413, VII. 21. The laboratory failed to monitor and document temperature for the storage of BD blood collection tubes and swab sets according to manufacturer's requirements for storage. Refer to D5413, VIII. 22. The laboratory failed monitor and document temperature for the storage of BD blood collection tubes and swab sets according to -- 8 of 53 -- manufacturer's requirements for storage. Refer to D5413, IX. 23. The laboratory failed to label gram stain reagent secondary containers with identity (including lot number) and poured/expiration dates. Refer to D5415, I. 24. The laboratory failed to ensure vials of mycobacteriology ATCC organisms were labeled with a preparation date and an expiration date specified by the manufacturer. Refer to D5415, II. 25. The laboratory failed to have documentation of the open date 6 of 6 bottles of Kinyoun and Auramine Rhodamine staining reagents. Refer to D5415, III. 26. The laboratory failed follow manufacturer's instructions to document the preparation date and revised expiration date for 3 of 3 prepared Bio Rad GS HIV Combo Ag/Ab EIA (Enzyme Immunosorbant Assay) reagents. Refer to D5415, IV. 27. The laboratory failed to ensure prepared reagents of saline stored in secondary containers were labeled with identification, concentration, poured dates, preparation dates, and expiration dates. Refer to D5415, V. 28. The laboratory failed to ensure alcohol reagent was not used past its expiration date. Refer to D5417, I. 29. The laboratory failed to ensure that Quantiferon TB Gold blood collection tubes were not expired prior to testing. Refer to D5417, II. 30. The laboratory failed to ensure blood collection containers did not exceed their expiration date. Refer to D5417, III. 31. The laboratory failed to ensure reagents, quality control (QC), calibration materials, and blood collection containers did not exceed their expiration date. Refer to D5417, IV. 32. The laboratory failed to have documentation of performing verification studies on the Evolis (Serial Number 9163701015) before testing for GS HIV Combo Ag/Ab EIA testing. Refer to D5421. 33. The laboratory failed to have documentation of performing all required daily (26 of 158 testing days), weekly (12 of 72 weeks), and monthly (5 of 18 months) maintenance. Refer to D5429. 34. The stat laboratory failed to implement an IQCP for syphilis health check when QC was tested less frequent than required. Refer to D5445. 35. The laboratory failed to follow their quality assessment plan for Cepheid Gene xpert MTB/RIF test. Refer to D5447. 36. The stat laboratory failed to document negative and positive control material for qualitative rapid plasma reagin (RPR) card test for 166 of 166 days from 05/2018 through 12/2018. Refer to D5449, I. 37. The stat laboratory failed to include negative and positive control material every day of patient testing for syphilis health check for 7 of 7 days from 07/2018 through 12/2018 (random sampling). Refer to D5449, II. 38. The main laboratory failed to document negative and positive control material for qualitative rapid plasma reagin (RPR) card test for 102 of 102 days in 2018 and 2019 (random sampling from 06/2018 through 10 /2018 and 01/2019). Refer to D5449, III. 39. The stat laboratory failed to establish criteria for acceptability of control material for quantitative rapid plasma reagin (RPR) card test for 3 of 3 lot numbers in 2018 (random sampling 05/2018 through 12/2018). Refer to D5469, I. 40. The main laboratory failed to establish criteria for acceptability of control material for quantitative rapid plasma reagin (RPR) card test for 2 of 2 lot numbers in 2018 and 2019 (random sampling from 06/2018 through 10/2018 and 01 /2019). Refer to D5469, II. 41. The laboratory failed to establish the criteria for acceptability and that statistical parameters (standard deviation, mean) for each lot number were defined and available for BioPlex 2200 Syphilis Total control material current lot (effective 10/22/2018). Refer to D5469, III. 42. The laboratory failed to check each batch of media for its ability to support growth, and as appropriate, select or inhibit specific organisms or produce a biochemical response. Refer to D5477. 43. The laboratory failed to have a system in place that twice a year defines the relationship between using two different panther instruments while testing anal /nasophargnal swabs and urine specimens for gonorrhea and chlamydia. Refer to D5775. 44. The laboratory failed to document