North Western Medical Laboratory

Summary Statement of Deficiencies D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on hematology quality control records review (years 2021-2022) and laboratory director interview on May 12, 2022 at 10:30 AM, it was determined that the laboratory failed to meet the analytic system requirements for Hematology specialty (sperm cell counts). Refer to D5543 (the laboratory failed to include on control material each 8 hours of operatiion when manual sperm cell counts were performed by hematocytomer reviewed on May 12, 2022 at 10:15 AM. D5543 HEMATOLOGY CFR(s): 493.1269(a)(d) (a) For manual cell counts performed using a hemocytometer-- (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on sperm count testing records review (years 2021-2022), lack of quality control records and laboratory director interview on May 12, 2022 at 10:30 AM, it was determined that the laboratory failed to include one control material each 8 hours of operation when manual sperm cell counts were performed by hemocytometer. The 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 -- findings include: 1. On May 12, 2022 at 10:00 AM, the records showed that the laboratory performed manual cell counts (sperm cell count) by the hemocytometer. 2. On May 12, 2022 at 10:15 AM , the records were reviewed from January 2021 to May 11, 2022 and showed that the laboratory did not include one control material each 8 hour of operation when 57 out 57 patients specimens were processed for sperm cell counts by the hemocytometer. 3. The laboratory processed and reported fifty seven (57) sperm count patient's samples from January 2021 to May 11, 2022. (2021=48 and 2022=9). 4. The laboratory director confirmed on May 12, 2022 at 10:30 AM, that the testing record not show any documentation of the control procedure. 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 hematology quality control records review and laboratory director interview on May 12, 2022 at 10:30 AM, it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory quality control requirements. Refer to D 6093. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control 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 hematology quality control records review (years 2021-2022) and laboratory diretor interview on May 12, 2022 at 10:30 AM, it was found that the laboratory director did not assure that the quality control procedures related to sperm cell counts were followed (The laboratory did not include any control material for sperm count test. Reviewed on May 12, 2022 at 10:15 AM). Refer D5543. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on hematology quality control records review (years 2021-2022) and laboratory director interview on May 12, 2022 at 10:30 AM, it was determined that the general supervisor did not assure that quality control procedures were followed by the testing personnel. (The laboratory did not include any control material for sperm count test. Reviewed on May 12, 2022 at 10:15AM). Refer to D5443. -- 2 of 2 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on manufacturer's instructions, tests reports records review and general supervisor interview on May 8, 2018 at 12:10 PM, it was determined that the laboratory failed to follow manufacturer's instruction when 98 out of 98 patients specimens were reported for Influenza A&B Quick vue method by Quidel from April 1, 2018 to April 30, 2018. January , 2018 to May 7, 2018. The findings include: 1 The laboratory validated the Influenza A&B Quick vue method by Quidel (waived tests) in December 2017. 2. The Influenza A&B Quick vue method by Quidel manufacturer instructions establish that the negative test is a presumptive results, the negative test results do not rule out possible other non-influenza viral infection and the positive test results do not rule out co-infections with other pathogens. 3. From January , 2018 to May 7, 2018, the laboratory reported 98 out of 98 patients specimens for Influenza A&B Quick vue method by Quidel and reported as negative or positive for Influenza A or Influenza B. The laboratory includes a reference value as Negative and the method identified as Immunoassay. 4. The general supervisor confirmed on May 8, 2018 at 12:10 PM, testing personnel confirmed on May 4, 2018 at 11:05 AM, that the Influenza A/B Quick vue method by Quidel reports did not include the required information. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) 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 -- 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: Based on lack of Statfax 4700 linearity check records and laboratory general supervisor interview on May 8, 2018 at 11:30 AM, it was determined that the laboratory did not have available the linearity check records of the Statfax 4700 system from January 2017 to to May 8, 2018. The findings include: 1. The laboratory did not have available the linearity check records of the Statfax 4700 system from January 2017 to to May 8, 2018. 2. The general supervisor confirmed on May 8, 2018 at 11:30 AM, that the laboratory did not have available the linearity check records of the Statfax 4700 system from January 2017 to to May 8, 2018. She stated that the laboratory director is who does the linearity check of the Statfax 4700 system and keeps those records and she is out of the country. D5012 SYPHILIS SEROLOGY CFR(s): 493.1207 If the laboratory provides services in the subspecialty of Syphilis serology, 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 syphilis serology quality control records ( years 2017 to 2018) review and general supervisor interview on May 8, 2018 at 10:10 AM, it was determined that the laboratory failed to ensure compliance with the analytic system requirements for syphilis serology tests. The finding includes: 1. The laboratory failed to follow the manufacturer's instruction when 11 out of 11 patients specimens patient specimen were tested for syphilis serology by Rapid plasma reagin (RPR) method from May 22, 2017 to April 18, 2018. Refer to D 5405. D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, 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 C reactive protein (CRP) and Rheumatoid Arthritis (RA) quality control records (years 2017 and 2018) review and general supervisor interview on May 8, 2018 at 10:50 AM, it was determined that the laboratory failed to ensure compliance with the analytic system requirements of General immunology for the CRP and RA quantitative tests. The finding includes: 1. The laboratory failed to include at least once a day, a negative control material and a positive control material when 11 out of 11 patients specimens were tested for CRP quantitative tests from January 27, 2017 to February 20, 2018 and when two out of two patients specimens were tested for RA quantitative tests from November 29, 2017 to February 15, 2018. Refer to D 5449. -- 2 of 6 -- D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on syphilis serology quality control records ( years 2017 to 2018) review and general supervisor interview on May 8, 2018 at 10:10 AM, it was determined that the laboratory failed to follow the manufacturer's instruction when 11 out of 11 patients specimens patient specimen were tested for syphilis serology by Rapid plasma reagin (RPR) method from May 22, 2017 to April 18, 2018. The findings include: 1. The manufacturer's instruction establishes that two levels of control material ( non reactive reactive) must be included each day of testing. 2. From May 22, 2017 to April 18, 2018, the syphilis serology quality control records showed that the laboratory did not include the two levels of control material when it processed and reported 11 out of 11 patients specimens for syphilis serology by RPR method the followings days: on May 22, 2017 ( one patient specimen), November 12, 2017 (one patient specimen), December 13, 2017 ( two patients specimens), January 12, 2018 (two patients specimens), February 1, 2018 (one patient specimen), February 20, 2018 (two patients specimens), March 6, 2018(one patient specimen) and April 18, 2018 (one patient specimen). 3. The general supervisor confirmed on May 8, 2018 at 10:15 that the syphilis serology quality control records did not include the quality control procedures those days. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on C reactive protein (CRP) and Rheumatoid Arthritis (RA) quality control records (years 2017 and 2018) review and general supervisor interview on May 8, 2018 at 10:50 AM, it was determined that the laboratory failed to include at least once a day, a negative control material and a positive control material when 11 out of 11 patients specimens were tested for CRP quantitative tests from January 27, 2017 to February 20, 2018 when two out of two patients specimens were tested for RA quantitative tests from November 29, 2017 to February 15, 2018. The findings include: 1. From January 27, 2017 to February 20, 2018, the CRP quality control showed that the laboratory did not include at least once a day, a negative control material and a positive control material when 11 out of 11 patients specimens were tested for CRP quantitative tests the following days: January 27, 2017 (one patient), November 7, 2017 (one patient specimen), November 10, 2017 (one patient specimen), November 29, 2017 (one patient specimen), January 4, 2018 ( three patients specimens), January 30, 2018 (two patients specimen) and February 20, 2018 -- 3 of 6 -- (two patients specimens). 2. From November 29, 2017 to February 15, 2018, the RA quality control showed that the laboratory did not include at least once a day, a negative control material and a positive control material when 2 out of 2 patients specimens were tested for RA quantitative on November 29, 2017 and February 15, 2018. 3. The general supervisor confirmed on May 8, 2018 at 10:50 AM, that the CRP and RA quality control records did not include the quality control procedures those days. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on syphilis serology quality control records ( years 2017 to 2018), C reactive protein (CRP) and Rheumatoid Arthritis (RA) quality control records (years 2017 and 2018) review and general supervisor interview on May 8, 2018 at 10:50 AM, it was determined that technical consultant failed to ensure compliance with the requirements for analytic systems of following tests: RPR, CRP and RA. The findings include: 1. The laboratory failed to follow the manufacturer's instruction when 11 out of 11 patients specimens patient specimen were tested for syphilis serology by Rapid plasma reagin (RPR) method from May 22, 2017 to April 18, 2018. Refer to D 5405. 2. The laboratory failed to include at least once a day, a negative control material and a positive control material when 11 out of 11 patients specimens were tested for CRP quantitative tests from January 27, 2017 to February 20, 2018 and when two out of two patients specimens were tested for RA quantitative tests from November 29, 2017 to February 15, 2018. Refer to D 5449. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on syphilis serology quality control records review in 2016-2017 and laboratory testing personnel interview on February 14, 2017 at 10:00 AM, it was determined that testing personnel failed to follow quality control procedures for the analytic systems of following tests: RPR, CRP and RA. The findings include: 1. The laboratory failed to follow the manufacturer's instruction when 11 out of 11 patients specimens patient specimen were tested for syphilis serology by Rapid plasma reagin (RPR) method from May 22, 2017 to April 18, 2018. Refer to D 5405. 2. The laboratory failed to include at least once a day, a negative control material and a positive control material when 11 out of 11 patients specimens were tested for CRP -- 4 of 6 -- quantitative tests from January 27, 2017 to February 20, 2018 and when two out of two patients specimens were tested for RA quantitative tests from November 29, 2017 to February 15, 2018. Refer to D 5449. 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 syphilis serology quality control records ( years 2017 to 2018), C reactive protein (CRP) and Rheumatoid Arthritis (RA) quality control records (years 2017 and 2018) review and general supervisor interview on May 8, 2018 at 10:50 AM, it was determined that the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the laboratory analytical system for the Syphilis Serology and General Immunology specialties. The findings include: 1. The laboratory director did not comply with the requirements in the the Syphilis Serology and General Immunology specialties. Refer to D 6093. 2. The laboratory director did not cumply with the laboratory records retention requirements. Refer to D 6079. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on lack of Statfax 4700 linearity check records and laboratory general supervisor interview on May 8, 2018 at 11:30 AM, it was determined that the laboratory director failed to ensure compliance with the laboratory records retention requirements. Refer D 3031 (The laboratory did not have available the linearity check records of the Statfax 4700 system from January 2017 to to May 8, 2018). D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. -- 5 of 6 -- This STANDARD is not met as evidenced by: Based on syphilis serology quality control records ( years 2017 to 2018), C reactive protein (CRP) and Rheumatoid Arthritis (RA) quality control records (years 2017 and 2018) review and general supervisor interview on May 8, 2018 at 10:50 AM, it was found that the laboratory director failed to ensure compliance with the analytic system requirements for the Syphilis Serology and General Immunology specialties. The findings include: 1. The laboratory director failed to ensure compliance with the analytic system requirements of Syphilis Serology specialty. Refer to D 5012. 2. The laboratory director failed to ensure compliance with the analytic system requirements of General Immunology specialty. Refer to D 5014. -- 6 of 6 --